Torrent Pharma Inc.
Apr 02, 2020Full 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**