1+ months

Manager, GMP Audits

Pfizer
Wuxi
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As assigned, independently lead or participate in GMP audits and assessments of Pfizer facilities, contract manufacturers, suppliers and GMP service providers involved in the manufacture, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide, including Pfizer Country Office locations with GMP responsibilities.



Assess if the contract manufacturer, supplier or GMP service provider is executing operations in compliance with cGMP requirements and guidelines, Pfizer Quality Standards and Quality Agreement requirements and Standard Operating Procedures.



As assigned, aid the PGS site or applicable contract manufacturer with focused assessments in preparation for upcoming regulatory inspections.



Assess whether employees are being properly trained for their responsibilities.



Assess continued adequacy of the facilities and equipment used for manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products.



Assess and report risks or weaknesses that could lead to non-compliant operations.



Communicate relevant quality and business information to the facility, contract manufacturer, supplier or GMP service provider audited, in an effort to maintain and enhance the relationship between the auditee and Pfizer.



Interpret regulatory and business challenges and best practices and recommend improvements or solutions to cGMP compliance issues at audited sites.



Lead or participate in GMP audits at Pfizer facilities, contract manufacturers, suppliers and GMP service providers. Responsibilities for this activity include but are not limited to:



+ Lead negotiations with auditees to schedule audits

+ Lead audit preparation activities including gathering of and review of auditee' relevant quality and performance metrics to determine risk-based audit scope

+ Lead the audit execution, or actively participate in the audit execution as directed by the lead auditor

+ Lead the preparation of audit reports

+ Lead the review and evaluate the adequacy of the auditee response to audit findings

+ Perform audit follow-up activities as required or as directed by leadership

+ In appropriate situations, initiate reviews through consultation and agreement with others, including subject matter experts



Maintain the appropriate audit database with relevant records and information pertaining to the lifecycle of assigned audits.



Maintain and expand current knowledge of applicable laws, regulations, guidelines, internationally recognize standards and other pertinent policies, procedures, and standards that could impact the auditee's operations.



Liaise between auditee and the appropriate Pfizer groups, to ensure that all pertinent information that could have an impact on the auditee's or Pfizer's business (e.g., auditee's regulatory inspection activities or significant changes) are requested, provided and documented.



Lead or participate in due diligence assessments as required to assess auditee's Quality compliance.



Apply technical knowledge to influence the design, planning and execution of cross functional projects.



Able to collaborate proactively with leadership, site personnel and subject matter experts, to enable a culture of excellence in independent objective audits and effective CAPAs.



Develop cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, risk-based analysis, critical thinking and innovative problem solving.



Lead or participate in department wide initiatives to advance the business strategy of the GMP audit function.



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



\#LI-PFE
Posted: 2021-03-11 Expires: 2021-05-20
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Manager, GMP Audits

Pfizer
Wuxi

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