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Quality System & Compliance Engineer


Hangzhou Plant
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Job Details


To execute quality compliance relevant activities and maintain site Quality Compliance Management systems under guidance from Quality System & Compliance Supervisor, with objective of ensuring product quality and the site operations are executed in light of cGMP, Pfizer Quality Standard (PQS) and site procedures.

+ Develop, supervise and execute site Quality compliance objective as per Pfizer global quality objective.

+ /cGMPPQS///Facilitate site Qualification/Validation activities, to ensure they are meet cGMP and PQS requirements. Review / approve relevant SOPs, protocols and reports as Quality representative. Qualification/Validation activities include but not limited to: Process Validation / Process Performance Qualification, Cleaning Validation, Analytical Method Validation, Utility and equipment qualification, Computerized System Validation and the corresponding revalidation.

+ cGMPPQSAdminister site Quality Risk Management system, Coordinate site QRM activities, maintain site Quality Risk Register, and supervise the execution of site QRM master plan, to ensure site QRM meet cGMP and PQS requirement;

+ cGMPPQS Fulfill the responsibility of site internal audit and walkthrough, to ensure site practice compliant to cGMP and PQS requirement, and work on continues improvement of site compliance. Support site audit program, includes but not limited to: Develop site internal audit and supplier audit plan; coordinate and participate site internal audit; Assist Pfizer global audit and Regulatory agency inspection etc.

+ Coordinate the implement of site Inspection readiness plan. It includes but not limited to: maintain a name list of site SSO and SME; Establish inspection readiness master plan; coordinate the implementation of inspection readiness plan, and track the completion status, complete periodic review of site Inspection Readiness Plan etc.

+ Participate in the development, implementation and tracking of site compliance plan, summary and escalate periodically.

+ GMPGMPDeliver GMP training as required, to improve the employee's GMP awareness and knowledge.


Execute any other related work assigned by company;

C:Plant Clock Standard - (China)

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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