1+ months

cGMP To execute quality compliance

Oviedo, Principado de Asturias 33012
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To execute quality compliance relevant activities and maintain site Quality Compliance Management systems under guidance from Quality System & Compliance Manager, with objective of ensuring product quality and the site operations are executed in light of cGMP, Pfizer Quality Standard (PQS) and site procedures.

** Role Responsibilities**

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

+ cGMPPQS Manage site internal audit program, to ensure site practice compliant to cGMP and PQS requirement, and work on continues improvement of site compliance. It includes but not limited to: Develop site internal audit annual plan, coordinate and participate site internal audit, perform periodic review and trend analysis for this program, develop site GMP auditors.

+ Drive site Inspection readiness plan and assist external audit/inspection hosting. It includes but not limited to: Establish and maintain SIRP (Site Inspection Readiness plan), maintain a name list of site SSO and SME; coordinate the implementation of inspection readiness plan, complete periodic review of site Inspection Readiness Plan etc.

+ Support supplier audit. Responsible for developing and execute audit plan for site managed suppliers.

+ PQS//PQSAs site contact of Pfizer Global compliance functions (such as PQS team/CAG/Regulatory Affairs), pay close attention to regulatory and PQS, manage gap analysis and comments feedback at site level, ensure site practice compliant with regulation requirements.

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

+ Responsible for local filing business and communication with local regulations, and support document collection for CTA and/or NDA.


Execute any other related work assigned by company;

** Qualification ( Minimum Requirements)**

+ **** **/ Education/Experiences**

+ 53GMPPharmaceutical, Chemical or Biological related Bachelor Degree; No less than 5 years of working experience in Pharmaceutical Quality (at least 3 years of working experience in equipment qualification or process validation of Biologics or Sterile/Aseptic manufacturing) , and proficient in GMP related knowledges;

+ **** **/ Specific Knowledge & Skil** ls

+ Biologics and Sterile/Aseptic manufacturing and quality management related knowledge;

+ Familiar with Quality Risk Management, and also the application of relevant tools.

+ Experienced on product process validation and equipment qualification.

+ officeGMP

Proficient in using English as working language at listening, speaking, writing and Proficient in Office application; Fully capable of establishing GMP Quality Management System; Effective Systematical Thinking and Communication ability; Good Coordination and Collaboration; Effective execution and result driving; Good at Problem solving and Quality Risk Management knowledge and Tool application;

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

Quality Assurance and Control
Posted: 2020-10-21 Expires: 2020-12-24
Sponsored by:
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cGMP To execute quality compliance

Oviedo, Principado de Asturias 33012

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