1+ months

Manager RQA GMP Audits

Pfizer
Hedgesville, WV 25427
Apply Now
Apply on the Company Site
As assigned, independently lead or participate in GMP audits and assessments of **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.



Assess if the auditee is executing operations in compliance with cGMP requirements and guidelines, Pfizer Quality Standards and Quality Agreement requirements and Standard Operating Procedures.



Assess whether employees are being properly trained for their responsibilities, as well as the adequacy of the facilities and equipment used for manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products.



Communicate relevant quality and business information to the, 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, report risks or weaknesses that could lead to cGMP compliance issues, and recommend improvements or solutions.



Lead or participate in GMP audits at **contract manufacturers, suppliers and GMP service providers. May participate in GMP audits of Pfizer facilities.** Responsibilities for these activities 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 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.



**Participate** in due diligence assessments as required to assess auditee's Quality compliance.



As assigned, aid the auditee in preparing for upcoming regulatory inspections.



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.



**Participate** in department wide initiatives to advance the business strategy of the GMP audit function.



As assigned, independently lead or participate in GMP audits and assessments of **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.



Assess if the auditee is executing operations in compliance with cGMP requirements and guidelines, Pfizer Quality Standards and Quality Agreement requirements and Standard Operating Procedures.



Assess whether employees are being properly trained for their responsibilities, as well as the adequacy of the facilities and equipment used for manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products.



Communicate relevant quality and business information to the, 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, report risks or weaknesses that could lead to cGMP compliance issues, and recommend improvements or solutions.



Lead or participate in GMP audits at **contract manufacturers, suppliers and GMP service providers. May participate in GMP audits of Pfizer facilities.** Responsibilities for these activities 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 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.



**Participate** in due diligence assessments as required to assess auditee's Quality compliance.



As assigned, aid the auditee in preparing for upcoming regulatory inspections.



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.



**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: 2021-02-26 Expires: 2021-06-28
Sponsored by:
ADP Logo

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manager RQA GMP Audits

Pfizer
Hedgesville, WV 25427

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast