Torrent Pharma Inc.

Torrent Pharma Inc. (TPI) is the 100% US subsidiary of Torrent Pharmaceuticals Ltd, a leading pharmaceuticals company in India with a growing presence in the global generics market. TPI was set up in 2004 and currently has 64 FDA approved generic products being commercialized in the US. Several products have leading market shares between 10-30% in their respective categories, including 14 products ranked in top 3. The company expects the US business to grow as it has rich pipeline of ANDAs and is expanding its manufacturing facilities in India.

TPI is an equal opportunity employer that embraces diversity in the workplace.

Torrent Pharma Inc.
Apr 02, 2020
Full time
The Quality Management Systems (QMS) Associate Director or Director oversees and actively participates in all aspects pertaining to Deviations, Investigations, Complaints, CAPA, Internal/External and Regulatory Audits, commitment tracking, and DEA. The QMS Associate Director/Director must be able to thoroughly and accurately complete/assist in the investigation of incidents / events which have occurred during the manufacturing, packaging, testing and storage of pharmaceutical products for determination of root cause and product impact per FDA regulations. In addition, he/she ensures that corrective and preventive actions (CAPA) based on investigation findings are identified and implemented to prevent occurrence/reoccurrence of the events. The QMS Associate Director/Director will report to the Head of Quality and will efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality. Essential Duties and Responsibilities: Lead and direct all QMS, Compliance and DEA related activities including but not limited to Deviations/Investigations, Complaints, CAPA, Change Control, OOS, Laboratory Investigations, Data Review, Internal/External/Regulatory Audits, and DEA quota, inventory and registrations. Ensures all investigations are extended to other batches or products as needed and completed in a timely manner. Oversees the implementation of the appropriate corrective and preventive actions (CAPA) to prevent occurrence/reoccurrence. Manage Effectiveness Checks to ensure they are performed by the required due date. Performs GAP analyses and risk assessments, and proactively implements quality policies and procedures in accordance with CGMP, and other regulatory requirements. Assists the Head of Quality in facilitating audits conducted by regulatory agencies, customers, and clients. Writes and prepares responses to audit findings by regulatory agencies, customers, and clients. Manages internal and external audit program; prepares yearly audit schedule. Reviews audit reports and responses for accuracy and completeness and provides follow-up on corrective actions and commitments. Manages customer complaints program. Reviews and approves complaint investigation reports and corrective actions. Manages investigations, audits and commitment tracking. Reviews and approve commitments. Provides training and guidance on conducting investigations and root cause analysis. Reviews and approves investigations for adequacy of root cause determination and CAPA. Makes decisions on disposition of Raw Materials, Finished Products, Components, Equipment impacted by the investigations. Guides other cross functional areas and prepares risk assessments. Prepares monthly metrics, trending charts, and meeting minutes. Escalates quality and Compliance issues in a timely manner. Evaluates and enhances site wide and departmental procedures and policies to ensure compliance with CGMPs, company policies, and other regulatory bodies Reviews and approves change controls, investigation, validation and qualification protocols and reports. Manages DEA reporting, cages, vaults in accordance with DEA regulations. Maintains all regulatory certifications, licenses, registrations including DEA. Manages within the allocated budget and resources Acts as a liaison between all cross functional departments to resolve compliance issues Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools Maintain knowledge of current regulatory requirements pertaining to pharmaceutical products Maintain effective communication and partnership with all departments across the organization Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations. Generate and facilitate changes to SOPs, policies, training materials, and other documents to assure compliance and continuous improvement. Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues. Proactive, good organizational and time management skills Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management. Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested. Interact with any and all other departments to resolve any issues regarding QMS Other duties may be assigned by the Head of Quality Safety Requirements: Ensure adherence to all personal protective equipment: Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources Competencies/Skills: Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask Demonstrated ability in working independently and as part of a team. Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance. Education and/or Experience: Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred. Minimum of ten (10) years of experience working in a GMP environment. Minimum of ten (10) years of experience in a Quality role in a pharmaceutical manufacturing environment. Lean, Six Sigma and cGMP experience preferred. Language Skills: ability to read and comprehend instructions in the English language through verbal and written method. ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization. Mathematical Skills: ability to interpret data utilizing intermediate math operations; statistical analysis Reasoning Ability: ability to apply common sense understanding to carry out multi-step instructions deal with standardized situations with occasional variables Physical Demands : Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. **Applicants must be able to commute daily to this location - - we are not currently offering any relocation**
Torrent Pharma Inc. Levittown, PA, USA
Apr 02, 2020
Full time
The Quality Management Systems (QMS) Manager or Sr. Manager oversees and actively participates in all aspects pertaining to Deviations, Investigations, Complaints, and CAPA. The QMS Manager/Sr. Manager must be able to thoroughly and accurately complete/assist in the investigation of incidents / events which have occurred during the manufacturing, packaging, testing and storage of pharmaceutical products for determination of root cause and product impact per FDA regulations. In addition, he/she ensures that corrective and preventive actions (CAPA) based on investigation findings are identified and implemented to prevent occurrence/reoccurrence of the events. The QMS Manager/Sr. Manager will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance or the Site Head of Quality.         Essential Duties and Responsibilities: Review and/or conduct thorough investigations and act as the Investigation Team Lead for Incidents/Deviations, OOS Investigations, Laboratory Events and Product Complaint Investigations as required following appropriate company procedures. Ensure all investigations are completed in a timely manner to support product release and regulatory compliance Ensure that all Incidents/Deviations, OOSs, Laboratory Events and Product Complaints are documented and tracked according to procedures. Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent occurrence/reoccurrence. Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools Manage CAPAs to ensure timely closure of actions resulting from various types of investigations. Provide metrics as requested to track/trend Incident, Event/Deviations, CAPA and Complaints. Manage Effectiveness Checks to ensure they are completed by the required due date and perform closure of Effectiveness Checks. Provide training on conducting investigations and performing root cause analysis as needed. Assist during regulatory inspections or other audits, as required Maintain knowledge of current regulatory requirements pertaining to pharmaceutical products Initiate SOP revisions as needed to assure compliance and continuous improvement. Maintain effective communication and partnership with all departments across the organization Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations. Generate and facilitate changes to SOPs, policies, training materials, and other documents. Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures. Assist staff regarding QMS processes. Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues. Proactive, good organizational and time management skills Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management. Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested. Interact with any and all other departments to resolve any issues regarding QMS documents Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality   Safety Requirements: Ensure adherence to all personal protective equipment: Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask         Demonstrated ability in working independently and as part of a team. Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance.                                 Education and/or Experience:                                                    Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred. Minimum of five (5) years of experience working in a GMP environment. Minimum of five (5) years of experience in a Quality role in a pharmaceutical manufacturing environment. Lean, Six Sigma and cGMP experience preferred.   Language Skills:                                                              ability to read and comprehend instructions in the English language through verbal and written method. ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization.   Mathematical Skills:                                                       ability to interpret data utilizing intermediate math operations; statistical analysis   Reasoning Ability:                                                          ability to apply common sense understanding to carry out multi-step instructions deal with standardized situations with occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.   Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. noise level in the work environment is usually moderate, but may be loud at times.
Torrent Pharma Inc. Levittown, PA, USA
Apr 02, 2020
Full time
The major responsibility of the Quality Control Laboratory Technician is to provide support to various laboratory functions including cleaning of laboratory glassware, maintaining laboratory cleanliness and tidiness, ordering laboratory supplies, chemicals and reagents. The Quality Control Laboratory Technician will maintain inventory for laboratory supplies, perform daily verification of laboratory equipment and basic Wet Chemistry testing.  Responsibilities will also include receiving in-coming samples in the laboratory and preparing samples and paperwork for outside testing. The Quality Control Laboratory Technician will report to the Quality Control Laboratory Group Lead and efficiently conduct all duties and responsibilities assigned, and/or delegated by the Head of Quality Control Laboratory or the Site Head of Quality.       Essential Duties and Responsibilities: Responsibilities include the following, but are not limited to: Perform daily verification and or calibration of laboratory equipment, i.e. pH meter, Balance, Karl fisher Receive and log incoming samples in the logbook Perform basic Wet Chemistry testing Preparation of solution, solvents and mobile phases Accurately documenting all tests/test materials/equipment used and all results obtained Work in accordance with approved methods, SOPs and cGMP/GLP and GDPs while performing tests Preparation of packaging components, Raw material, finished product, stability samples and related request form for outside laboratory testing Cleaning and organizing the laboratory glassware Maintain the laboratory in clean and organize manner Ordering laboratory supplies, chemicals and reagent Moving of sample and chemical waste to designated area for destruction. Adheres to safety regulation and OSHA procedure. Executes assigned tasks within established timelines Complies with company policies, procedures, rules and regulations Maintains confidently and communicates effectively Works with computers as well as laboratory software as needed   ADDITIONAL RESPONSIBILITIES: Maintains and demonstrates a high level of personal and professional integrity Reports any suspicious activity to laboratory management Assists Laboratory Management on special projects and assignments Additional responsibilities may be assigned by Laboratory Management as needed   QUALITICATIONS: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed represent the knowledge, skills, and ability required for this role.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word Ability to work independently and as part of team, self-motivation, adaptability and positive attitude Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Ability to work in a detail-oriented manner Ability to meet attendance standards: All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.   Education and Experience: Bachelor’s degree in Science Field, Chemistry Degree preferred one or more years of experience GMP laboratory environment Experience and knowledge of basic laboratory operations such as weighing and preparing solution Ability to follow laboratory procedure with technical content, quality and safety with instruction Must have knowledge of safe handle of chemicals and reagents Must be able to operate a laboratory glassware washer                 Language Skills:                                                              Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and groups within the organization.   Mathematical Skills:                                                      Ability to interpret data utilizing intermediate math operations Ability to perform simple analytical calculations   Reasoning Ability:                                                         Ability to apply common sense understanding to carry out multi-step instructions Ability to deal with standardized situations including occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear Frequently lift and/or move up to 25 pounds Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus   Work Environment: Noise level in the work environment is usually moderate but may be loud at times
Torrent Pharma Inc. Levittown, PA, USA
Apr 02, 2020
Full time
The Compliance Associate oversees and conducts internal and external audits. Routine job responsibilities include the evaluation of all departments and associated documentation for adherence to Torrent procedures and regulatory requirements as well as providing support during regulatory or customer audits of Torrent Pharma. The Compliance Associate/Senior Associate will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance or the Site Head of Quality.       Essential Duties and Responsibilities: Prepare the annual schedule for internal audits, conduct and document internal audits, track and provide follow-up on corrective actions Work closely with personnel in all departments ensuring procedures are being followed and documentation requirements are being performed as required to ensure product quality and compliance to company procedures and regulatory requirements Support external, regulatory or certification audits and interact with FDA as needed Coordinate interdepartmentally and draft responses to external and regulatory audits Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent deviation occurrence/reoccurrence Manage CAPAs to ensure timely closure of actions resulting from various types of audits Track and provide follow-up to corrective actions and commitments pertaining to external and regulatory audits Manage Effectiveness Checks to ensure they are completed by the required due date and perform closure of Effectiveness Checks Provide metrics as requested to track/trend audit observations Performs analysis of key quality indicators and analyzes data to identify areas for improvement in the quality system Generates and facilitates changes to SOPs, policies, training materials, and other documents to assure compliance and continuous improvement. Assists in the QA review of investigations, root cause analysis, and Corrective and Preventive Action (CAPA) plans related to process / product deviations, material testing, and Out-of-Specification events Notifies management of quality/compliance trends. Maintains knowledge of current regulatory requirements pertaining to pharmaceutical products Maintains effective communication and partnership with all departments across the organization Maintains a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations. Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues. Proactive, good organizational and time management skills Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management. Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested Interact with any and all other departments to resolve any issues regarding internal/external audits Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality   Safety Requirements: Ensure adherence to all personal protective equipment: Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask         Demonstrated ability in working independently and as part of a team Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance                                 Education and/or Experience:                                                    Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred. Minimum of three (3) years of experience working in a GMP environment. Minimum of three (3) years of experience in a Quality role in a pharmaceutical manufacturing environment. Lean, Six Sigma and cGMP experience preferred.   Language Skills:                                                              ability to read and comprehend instructions in the English language through verbal and written method. ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization.   Mathematical Skills:                                                       ability to interpret data utilizing intermediate math operations; statistical analysis   Reasoning Ability:                                                          ability to apply common sense understanding to carry out multi-step instructions deal with standardized situations with occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.   Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise level in the work environment is usually moderate, but may be loud at times.
Torrent Pharma Inc. Levittown, PA, USA
Apr 02, 2020
Full time
The major responsibility of the Quality Control Technical Writer is to write, review, revise and maintain analytical technical documents within the Quality Control Laboratory. The Technical documents include, but are not limited to testing Methods, Specifications, Standard Operating Procedures, Technical Transfer Documents, Method Validation, Verification protocols and reports. The Quality Control, Technical Writer will also manage documentation compliance, change control for the quality control laboratory and will be responsible for writing laboratory deviations and investigations. The Quality Control Technical Writer will report to the Head of Quality Control Laboratory and efficiently conduct all duties and responsibilities assigned, and/or delegated by the Head of Quality Control Laboratory or the Site Head of Quality.       Essential Duties and Responsibilities: Write, review and revise the following documents Analytical Methods and Specifications Pre and Post approval Stability protocols Method Validation, Verification, Transfer, and Experimental Protocols and Reports SOPs pertaining to laboratory equipment and operation Forms, checklists, and training quizzes associated with SOPs Reviews and revises documents prepared by others and coordinates the preparation of those materials for completed documents Reviews and edits complex written technical materials for accuracy, clarity, and completeness Initiates change controls for analytical document implementations and revisions Address comments from SMEs and different stake holders to finalize/approve the analytical documents, and follows up for their approval process in a timely manner to meet the targeted timelines Perform GMP technical data review for analytical activities such as; but not limited to; method validation, method transfer, method verification and testing of Stability Submission batches Support laboratory investigations including, identification of root cause, identification and implementation of appropriate corrective and preventative actions, authoring the final investigation report, and writing the impact assessments Ensure investigations adhere to compliance-driven timelines and are compliant with cGMP regulations Providing quality and technical support to Laboratory Manager, Group Leaders, as well as Scientist and Laboratory Technicians Support key projects for Laboratory Operations aimed at elevating compliance Maintain periodic review of Laboratory SOPs Knowledge of FDA/ICH guidelines with respect to FDA’s current requirements for method validation, verification, transfer, and stability Demonstrates the ability to prioritize conflicting demands Executes assigned tasks within established timelines Develops and maintains expertise in chemistry and pharmaceutics through a professional education and training Complies with company policies, procedures, rules and regulations Maintains confidently and communicates effectively Works with computers as well as laboratory software as needed   Additional Responsibilities: May require technical review of previously generated data for regulatory responses Maintains and demonstrates a high level of personal and professional integrity Reports any suspicious activity to laboratory management Assists Laboratory Management on special projects and assignments Additional responsibilities may be assigned by Laboratory Management as needed   QUALITICATIONS: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed represent the knowledge, skills, and ability required for this role.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word Proficient in technical writing Ability to learn quickly, perform multiple tasks simultaneously, keep accurate record, follow instructions and comply with company policies Ability to work independently and as part of team, self-motivation, adaptability and positive attitude Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of USP and ICH guidelines Ability to work in a detail-oriented manner Ability to meet attendance standards: All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.   Education and Experience: Bachelor’s degree or higher in Science Field, Chemistry Degree preferred Three or more years of demonstrated excellence in the field of analytical chemistry Three or more years of experience in writing analytical technical documents Experience troubleshooting Laboratory Deviations Knowledge of cGMP and related compliance regulation and guidance is required Prior experience in a pharmaceutical (cGMP) laboratory setting is required Prior Technical writing experience preferred                Language Skills:                                                                Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and groups within the organization.   Mathematical Skills:                                                         Ability to interpret data utilizing intermediate math operations Ability to perform complicated analytical calculations and statistical analysis   Reasoning Ability:                                                           Ability to apply common sense understanding to carry out multi-step instructions Ability to deal with standardized situations including occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear Frequently lift and/or move up to 25 pounds   Work Environment: Noise level in the work environment is usually moderate but may be loud at times
Torrent Pharma Inc. Levittown, PA, USA
Apr 02, 2020
Full time
The major responsibility of the Quality Control Chemist is to perform physical and chemical testing on raw materials, packaging component, in-process, finished products, stability samples, cleaning verification, cleaning validation, process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies. He/she follows and maintains adherence to current industry standards (cGMPs, GLPs, etc.) to meet production and customer demand. Qualified candidates will be expected to work either independently or as a team to achieve company goals and initiatives. The Quality Control Chemist will report to the Quality Control Laboratory Group Lead and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality Control, Laboratory Manager or the Site Head of Quality.        Essential Duties and Responsibilities: Responsibilities include the following. Other duties may be assigned.   Perform analytical testing of raw materials, in-process, finished product and/or stability samples, cleaning verification, cleaning validation, and process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies Testing includes, assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and other tests according to the analytical methods, USP, procedures in a regulated laboratory environment Analyze samples using appropriate instrumentation such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, Karl Fisher (KF), pH, Viscometer etc. Perform instrument calibration such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, Karl Fisher (KF), pH, Viscometer etc. Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner Process and report the analysis results using the instrument specific data processing software Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation Performs investigative testing or other functions to assist with laboratory investigations Follow all SOPs, Safety Guidelines and good housekeeping practices to ensure compliance with cGMP and Housekeeping requirements Identify and troubleshoot problems with instrumentation and analytical preparations Maintain lab work area in a neat and orderly fashion Assists in execution of training and acts as a mentor to less-experienced analysts Works in support of production and development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments Works with computers as well as laboratory software, or proprietary software as needed   ADDITIONAL RESPONSIBILITIES: Responsibilities for the appropriate documentation and disposal of unused laboratory samples and expired reagents Maintain and demonstrate a high level of personal and professional integrity and Report any suspicious activity to laboratory management Assists Laboratory Management on special projects and assignments Additional responsibilities may be assigned by Laboratory Management as needed QUALITICATIONS: To perform this job successfully, an individual must be able to perform each essential Duty satisfactorily. The requirements listed are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask         Demonstrated ability in working independently and as part of a team Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines. Must have a teamwork attitude   Education and/or Experience: Minimum B.S. Degree in Science Field Chemistry Degree Preferred. 1 or more years of experience in an analytical laboratory in pharmaceutical or related field of analytical chemistry Experience in testing raw materials, in-process, finished products and/or stability samples such as assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and related testing in an FDA regulated laboratory environment required Basic understanding of cGMPs and compendia procedures where applicable (i.e., USP, NF, BP, etc.) required Demonstrated technical expertise in laboratory instruments, i.e. HPLC, UPLC, GC, UV, Karl Fisher. Experience in instrument calibration i.e. HPLC, UPLC, GC, Dissolution apparatus, UV, IR preferred Experience with Empower or related lab software preferred Prior experience in a pharmaceutical (cGMP) laboratories setting is required                 Language Skills:                                                     Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and in a group of employees within the organization.   Mathematical Skills:                                                            Ability to interpret data utilizing intermediate math operations; perform complicated analytical calculations and statistical analysis Reasoning Ability:                                                             Ability to apply common sense understanding to carry out multi-step instructions Deal with standardized situations with occasional variables Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. Frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise level in the work environment is usually moderate but may be loud at times.
Torrent Pharma Inc. Levittown, PA, USA
Mar 23, 2020
Full time
The Health, Safety, Security and Environmental Manager will manage, coordinate and overseeing implementation of all health, safety, security and environmental (HSE) program and process at the location. EHS Manager should have a minimum of 7 years experience in pharmaceutical industry, GMP, Responsibilities for the EH&S Manager Design the local process, follow up on non-conformances and develop the systems to resolve them. Develop performance standards and methods of accomplishing those standards for the facility. Completes and/or approves all required regulatory and company reporting documents. Ensure appropriate risk assessments are conducted, follow up implemented in each functional area (HSE) to minimize or eliminate accidents, asset losses, security breaches and environmental issues that might cause harm to one of the company's employees, contractors, visitors, assets or reputation. Provide HSE expertise for all new projects and change management activities Ensure training and coaching is taking place to ensure Health, Safety, Security and Environmental standards and awareness, are well understood throughout the plant organization. Organize the annual training plan as needed, personally conducts or oversee high priority topic training. Coach the site staff on their specific roles and responsibilities as visible leaders.   Requirements for the EH&S Manager Experience in / drugs, food product industry GMP principles Bachelor's Degree required Minimum 5 years' experience in Industrial Health, Safety and/or Environmental, and Security management role / 7 years' experience in a manufacturing environment, solid working knowledge of federal, state and local regulations In-depth knowledge of OSHA and state standards as they apply within the facility   Basic Qualifications: Bachelors in Science preferred. Strong Windows applications and the MS Office (Word, Excel, Outlook) package. 7 years’ experience in Pharmaceutical Manufacturing required Strong oral and written communication skills. Good interpersonal and communication skills to deal with an array of different departments and outside vendors. Ability to establish detailed project timelines, execute tactical plans and maintain established deliverables. Demonstrated problem solving skills in identifying and resolving issues. Ability to develop and maintain strong working relationships with primary support functions; Operations, Quality Ability to quickly learn process, procedure and technical aspect of Legacy Demonstrated ability to create procedures Ability to quickly adapt and contribute Strong desire to contribute to organization from technical platform Good people and collaboration skills Ability to use informal influence to produce results Ability to develop and manage aggressive timelines Willingness to work hours outside of the normal established office hours Ability to work autonomously, producing necessary results with minimal supervision/oversight Ability work in a controlled and regulated environment. Excellent verbal and written communication skills and ability to work collaboratively in a cross functional team environment. Knowledge of Food and Drug Administration (FDA) guidelines and cGMPs.
Torrent Pharma Inc. Levittown, PA, USA
Mar 23, 2020
Full time
Summary: The major responsibility of the Operations Technical Writer is to write, review, revise and maintain technical documents within the Production and Engineering departments. The Technical documents include, but are not limited to Manufacturing and Packaging Master Production Records, Production and Engineering Deviations, Events, Investigations and Standard Operating Procedures related to the position. The Operations Technical Writer will report to the Site Head and efficiently conduct all duties and responsibilities assigned, and/or delegated by the Site Head.     Essential Duties and Responsibilities: Responsibilities include the following but are not limited to: Write, review and revise the following documents in support of Production and Engineering Manufacturing and Packaging Master Records Events Deviations Investigations Relevant SOP’s Reviews and revises documents prepared by others and coordinates the preparation of those materials for completed documents Reviews and edits complex written technical materials for accuracy, clarity, and completeness Address comments from SMEs and different stake holders to finalize/approve the documents, and follows up for their approval process in a timely manner to meet the targeted timelines Ensure investigations adhere to compliance-driven timelines and are compliant with cGMP regulations Demonstrates the ability to prioritize conflicting demands Executes assigned tasks within established timelines Complies with company policies, procedures, rules and regulations Maintains confidently and communicates effectively   ADDITIONAL RESPONSIBILITIES: May require technical review of previously generated data for regulatory responses Maintains and demonstrates a high level of personal and professional integrity Reports any suspicious activity to management     QUALIFICATIONS: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed represent the knowledge, skills, and ability required for this role.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word Proficient in technical writing Ability to learn quickly, perform multiple tasks simultaneously, keep accurate record, follow instructions and comply with company policies Ability to work independently and as part of team, self-motivation, adaptability and positive attitude Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Must be able to communicate technical, scientific, and regulatory information, both written and verbally Ability to work in a detail-oriented manner Ability to meet attendance standards: All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.   Education and Experience: Bachelor’s degree or higher in Science Field, Engineering, Pharmacy preferred Three or more years of demonstrated excellence in the field Three or more years of experience in writing technical documents Knowledge of cGMP and related compliance regulation and guidance is required                 Language Skills:                                                              Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and groups within the organization.   Reasoning Ability:                                                         Ability to apply common sense understanding to carry out multi-step instructions Ability to deal with standardized situations including occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear   Work Environment: Noise level in the work environment is usually moderate but may be loud at times
Torrent Pharma Inc. Levittown, PA, USA
Mar 16, 2020
Full time
The Facility Engineer participates, coordinates and executes technical optimization projects and oversees ongoing maintenance and operation of the facility, and equipment, and utilities including purified water systems, compressed air systems, boilers, HVAC systems, and packaging and manufacturing equipment. He/she shall fully comply with all regulatory / cGMP guidelines, standards, and policies. This position reports to the Manager, Engineering.   Major Tasks, Key Responsibilities and Key Accountabilities: Personnel in this position will adhere to all cGMPs, compliance/regulatory mandates and quality requirements. Develop equipment Specifications (User Requirements and Functional Specifications). Develop and review specifications and submittals. Participate, coordinate and execute Factory Acceptance Testing (FAT’s) Develop and execute Design of Experiments (Engineering Studies) for process/packaging process Assist in development and review of Installation, Operation, and Performance Qualification. Participate and/or execute Packaging Line/Process/Facility Qualification and Validation activities. Assist in troubleshooting equipment and utility malfunctions and breakdowns. Champion Operational Improvement initiatives Provide technical or consulting inputs on process or equipment modification. Establish/maintain key performance indicators. Support maintenance and/or facilities management activities as needed. Support technical & process disciplines in internal and external project efforts. Support and maintain cGMP critical instrument PM’s, calibrations, repairs. Supports investigations and assist in development and implementation of CAPAs. Other related duties as assigned to meet departmental and Company objectives. Responsible for establishing and maintaining inventory of spare parts. Responsible for measuring and recording measurements (voltage, amperage, RPM, etc.) and maintaining proper documentation regarding equipment/system performance and maintenance. Responsible for notifying supervisor or manager regarding equipment performance and maintenance. Must participate and successfully complete all training as required by the company.                                                                                                                                                                                   Responsible for overseeing the activities of contractors working on-site and ensuring they are trained on the appropriate procedures and systems, prior to performing work. Commitment to high level of ownership of safety, hygiene, quality and cGMP practices. Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, calibration, and operation of equipment, facility, and utilities. Follows all department SOPs and all applicable company SOPs. Prepare for and participate in both internal and external safety and cGMP audits Assist in developing and revising standard operating procedures. Responsible to prepare and update drawings and layouts using AutoCad. Responsible for training and development of new and current employee on manufacturing responsibilities including cross-training to maximize departmental knowledge Participate in department or company projects/initiatives as requested. Interact with Operations/Manufacturing, Quality, R&D, Supply Chain, etc. to resolve any issues regarding manufacturing and production related processes.   Qualifications/Competencies/Skills:   Good interpersonal and communication skills to deal with an array of different departments and outside vendors. Demonstrated oral and written communication skills. Strong Technical Writing skills. Ability to establish detailed project timelines, execute tactical plans and maintain established deliverables. Demonstrated problem solving skills in identifying and resolving issues. Ability to develop and maintain strong working relationships with primary support functions; Operations, Quality, and Safety. Experience with Computerized Systems including Quality Managements Systems and ERP systems. Proficient with Microsoft office with working knowledge of Microsoft Project. Proficient with AutoCad or AutoCad LT. Demonstrated ability to follow simple and complex procedures. Ability to quickly adapt and contribute. Strong analytical thinking and the ability to articulate rationale in a clear and concise manner. Ability to develop and manage aggressive timelines. Ability and willingness to work flexible hours including hours outside of the normal established office hours. Great attention to detail, quality and a desire for success. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Self-motivated individual with the ability to lead/drive through the change management cycle. Ability to write routine reports and correspondence. Ability to work autonomously, producing necessary results with minimal supervision/oversight Ability work in a controlled and regulated environment. Excellent verbal and written communication skills and ability to work collaboratively in a cross functional team environment. Knowledge of Food and Drug Administration (FDA) guidelines and cGMPs.   Education and/or Experience:                                                  Bachelor of Science in an Engineering related field (Mechanical, Chemical, Electrical, Manufacturing) and minimum of 2-5 years relevant pharmaceutical manufacturing experience. Lean Manufacturing Experience a plus.   Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Frequently exposed to moving mechanical parts; high, precarious places and risk of electrical shock. The employee is occasionally exposed to wet and/or humid conditions; fumes or airborne particles; toxic or caustic chemicals; outside weather conditions; extreme cold and extreme heat. Noise levels in the work environment is usually moderate to loud.