Quality Control Supervisor

7 days 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 across all relevant manufacturing sites.
  • Execute reviews and ensure management and closure of any associated deviations within Pfizer's Quality Management System (QMS).
  • Notify management of any changes that may require adjustments to marketing authorization, manufacturing licenses, or GMP clearances as per Pfizer's procedures.
  • Assist in the preparation of reports for the Area Quality Review Team (A-QRT/SQRT) and participate in related meetings.

Notification to Management:

  • Inform the SCMOQ China Lead Team of significant deviations and any issues affecting marketed products.
  • Implement local actions identified during Area Quality Review Team (AQRT) meetings, such as recalls and communication with regulatory agencies.

Change Control Management:

  • Ensure all change initiations include all relevant information and attachments.
  • Coordinate with initiators to open occurrence records in the Quality Tracking System (QTS).
  • Ensure all change implementations comply with the requirements of the change process.

Quarantine Alert Notices:

  • Ensure timely receipt and processing of quarantine alert notices.

Commitment Tracking:

  • Ensure completion of commitments related to regulatory, internal audits, and deviations as required.

Market Actions:

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

Product Quality System:

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

Product Disposition:

  • Review Certificates of Analysis (COA), Certificates of Compliance (COC), and other relevant information for finished products.
  • Conduct transactions in Systems, Applications, and Products (SAP).
  • Oversee returned goods and ensure effective local batch release.
  • Assess temperature deviations using available data or plant support and provide batch disposition.
  • Coordinate regular quality review meetings with the distribution warehouse quality unit.
  • Liaise with External Supply Operations Quality (ESOQ) and manufacturing sites to determine disposition of products experiencing temperature excursions.
  • Ensure proper record-keeping for inspections and evaluations against appropriate specifications.
  • 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 and coordination for inspections by regulatory authorities or Pfizer internal auditors.
  • Prepare and align with SCMOQ management on action plans to address issues identified during inspections or audits.
  • Track implementation of identified actions within agreed timelines.

Local Contractor Quality Oversight:

  • Ensure effective quality oversight of local contractors, including logistics service providers and re-packers.
  • Maintain quality agreements that reflect current requirements.
  • Review quality performance and agree on action plans for continuous improvement.
  • Communicate critical regulatory inspection observations and audit findings to SCMOQ management and provide input into corrective action plans.
  • Provide quality due diligence for local contractors and ensure timely resolution of corrective actions.

Product Complaint Handling:

  • Support domestic product manufacturers in completing product quality complaint investigations.
  • Intake and triage complaints, forwarding them for expedited investigation.
  • Notify local and global management of expedited complaints.
  • Receive and assess complaint samples.
  • Prepare product complaint investigation packages and track follow-up actions.
  • Conduct technical evaluations of investigation data and reports.
  • Review corrective and preventative actions and escalate complaint trends to management.

Training:

  • Create standard operating procedures (SOP) or other on-the-job training courses.
  • Establish training curricula and assign training as required.
  • Prepare annual training plans and track progress.
  • Complete assigned training sessions.

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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