1+ months

Sr. Manager RQA GMP Audits

Hedgesville, WV 25427
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Regulatory Quality Assurance (RQA) is an independent Quality audit function accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations. Within RQA, the GMP Audit function is responsible for performing GMP audits to Pfizer facilities, contract manufacturers, suppliers and GMP service providers involved in the manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide. The RQA GMP Audit function is accountable to ensure Pfizer manufacturing operations are compliant with all applicable global regulations and GMP standards, as well as Pfizer Quality Standards. The RQA GMP Audit function is required to understand GMP regulations worldwide and apply this expertise when performing audits, to provide assurance against regulator's interpretation and expectations for compliance with cGMP requirements. RQA is part of the Pfizer Corporate Compliance Division.

The Senior Manager RQA GMP Audits, position is responsible for performing independent GMP audits and assessments of contract manufacturers, suppliers and GMP service providers. The Senior Manager RQA GMP Audits will assess processes, systems and procedures, to evaluate their quality performance against established standards and regulatory agency guidelines. This position leads independent GMP audits and inspection preparation activities, resolution of audit and inspection findings, and liaises with appropriate site quality and above site quality teams through all stages of the audit lifecycle. The Senior Manager RQA GMP Audits may lead or participate in complex cross functional projects. This position contributes to enabling a culture of innovation, excellence and continuous improvement of the company's Quality Management System, through engagement with Pfizer site audit teams to incorporate audit outcomes and best practices across the Pfizer manufacturing and supply network. Quality: http://www.pfizer.com/about/quality


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: 2020-11-02 Expires: 2021-02-08
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Sr. Manager RQA GMP Audits

Hedgesville, WV 25427

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