Supply Chain Compliance Supervisor

2 months ago

Suzhou, Jiangsu, China Pfizer Full time

Resolution of Product Quality Compliance Issues

Deviation Management:

Ensure closure of any investigations, out-of-specifications, change controls, complaints, and other quality-related matters throughout the production process from all associated manufacturing sites.

Execute reviews and ensure any associated deviations are managed and closed within the quality management system.

Notify management of any changes that may require a variation to marketing authorization, manufacturing license, or GMP clearance as per company procedures. Assist in drafting reports for the Area Quality Review Team and participate in relevant meetings.

Notification to Management

Inform management of significant deviations and any issues impacting marketed products. Implement actions identified during Area Quality Review Team 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. 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 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, communicating with relevant teams regarding quality-related action items.

Product Disposition

Review certificates of analysis and any other relevant information for finished products. Conduct transactions in the systems and applications used for product management. Oversee the handling of returned goods. Ensure effective and efficient local batch release processes. Assess temperature deviations and execute batch disposition as necessary. Coordinate regular quality review meetings with distribution warehouse quality units. Collaborate with external quality operations and manufacturing sites to determine disposition of products affected by temperature excursions. Ensure a management system is in place for quality oversight. Maintain records for inspections and evaluations in accordance with 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 internal auditors. Prepare responses and action plans to address issues identified during inspections or audits. Track the 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 management. Provide quality due diligence for local contractors and ensure timely resolution of corrective actions.

Product Complaint Handling

Support domestic manufacturers in completing product quality complaint investigations. Receive and classify complaints for expedited investigation. Notify management of expedited complaints. Receive and assess complaint samples. Forward complaints to relevant plants or conduct technical assessments. Prepare investigation packages for product complaints. Track and follow up on investigations. Conduct technical evaluations of investigation data and reports. Review corrective and preventive actions. Escalate complaint trends to management.

Training

Create standard operating procedures or other on-the-job training courses. Establish training curricula and assign training as needed. 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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