Quality Management Systems (QMS) Manager

  • Torrent Pharma Inc.
  • Levittown, PA, USA
  • Jul 20, 2020
Full time Quality Control

Job Description

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.