Quality Assurance Supervisor

2 months ago

Suzhou, Jiangsu, China Pfizer Full time

Resolution of Product Quality Compliance Issues

Deviation Management:

  • Ensure closure of all investigations, out-of-specifications, change controls, complaints, and any other quality-related matters throughout the production process from all associated manufacturing sites.
  • Execute reviews and ensure that any associated deviations are managed and closed within the Quality Management System.
  • Notify management of any changes that may require variations to marketing authorization, manufacturing licenses, or GMP clearance as per established procedures.
  • Assist in the preparation of reports for the Area Quality Review Team and participate in relevant meetings.

Notification to Management:

  • Inform the management team of significant deviations and any issues affecting marketed products.
  • Implement local actions identified during Area Quality Review Team meetings, such as recalls and communication with regulatory agencies.

Change Control Management:

  • Ensure that all change initiations include all relevant information and attachments.
  • Coordinate with initiators to open occurrence records in the Quality Tracking System.
  • Ensure compliance with change process requirements during implementation.

Quarantine Alert Notices:

  • Ensure timely receipt and processing of quarantine alert notices.

Commitment Tracking:

  • Ensure completion of regulatory, internal audit, and deviation commitments as required.

Market Actions:

  • Support local market action teams and ensure effective completion of all necessary actions.

Product Quality System:

  • Confirm compliance with global standard operating procedures, complete gap analysis reports, and conduct training.
  • Monitor local quality performance metrics and implement actions upon identifying trends or issues.
  • Assess and implement any new or updated regulatory requirements.
  • Participate in continuous improvement initiatives for processes and systems.
  • Complete annual product reports in accordance with regulatory timelines.
  • Engage in post-marketing changes for imported products and communicate with relevant stakeholders regarding quality-related action items.

Product Disposition:

  • Review Certificates of Analysis and any other relevant information for finished products.
  • Conduct transactions in the Systems, Applications, and Products environment.
  • Oversee the return of goods and ensure efficient local batch release.
  • Assess temperature excursions and provide batch disposition based on available data.
  • Coordinate regular quality review meetings with the distribution warehouse quality unit.
  • Ensure proper management of records for inspections and evaluations.
  • Implement appropriate batch disposal for returned and non-conforming products.
  • Complete pre-launch preparations and market release of new products.

Inspections and Internal Audit:

  • Lead preparation for regulatory inspections and internal audits.
  • Coordinate responses and action plans to address issues identified during inspections.
  • Track the implementation of identified actions within agreed timeframes.

Local Contractor Quality Oversight:

  • Ensure effective quality oversight of local contractors.
  • Maintain quality agreements that reflect current requirements.
  • Review quality performance and establish action plans for continuous improvement.
  • Communicate critical regulatory inspection observations to management.
  • Provide quality due diligence for local contractors and ensure timely closure of CAPAs.

Product Complaint Handling:

  • Support domestic manufacturers in completing product quality complaint investigations.
  • Receive and classify complaints for expedited investigation.
  • Notify management of expedited complaints.
  • Assess complaint samples and prepare investigation packages.
  • Track and follow up on investigations and review corrective actions.
  • Escalate complaint trends to management.

Training:

  • Create standard operating procedures and on-the-job training courses.
  • Establish training curricula and assign training as required.
  • Prepare annual training plans and track progress.
  • Complete assigned training as necessary.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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