Jobs

• 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 recognized 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.

Bachelor’s Degree in pharmaceutical sciences or equivalent required.

Minimum 10 years of progressive, challenging experience in the biopharmaceutical industry required, inclusive of quality control / assurance, manufacturing and GMP auditing (may include Product Development).

Proven knowledge and experience in GMP auditing of at least 3 technology platforms and areas of specialization such as small molecules, biologics, medical device combination products, active pharmaceutical ingredients, aseptic operations, non-aseptic operations, laboratory operations (chemistry, microbiology, specialized), advanced therapies, computerized systems, software as medical device, good distribution practices, and Pfizer country offices.