1. Regulatory Compliance Monitoring
Monitor PQS update and site compliance assessment. Monitoring and assessment of Regulatory Compliance (e.g. : PIC / S GMP, EU GMP, WHO GMP, GHP etc.
Monitoring of Regulatory findings in Pfizer PGS sites and industry.
2. Internal Audit & External Audit Activities
Responsible for inspection readiness of internal and external audit. Daily audit report preparation for BOH inspection. Coordination of inspection preparation.
Support for Supplier audit. SSA planning and execution.
3. Internal Audit & External Audit Commitment Handling
Coordinate the planning of inspection CAPAs. Follow up the commitment status and the quality of closure.
4. Supervise people
Supervise people for the areas of site CNM, Food registration, material compliance and supplier management..
5. Maintain SOP of Compliance
Initiate or revise SOP for regulatory and PQS compliance
Degree : Bachelor Degree
Field : Pharmaceutical, Chemistry Biology, Food Industry, Nutrition or related science.
5 years of Quality / Compliance experience in Pharmaceutical industry, and nice to have experience in Production / Technical Service / RA affairs
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.