As aGMP Quality Auditor you will be responsible for planning, coordinating and performing pre, during and post-audit activities for assigned audits.
You will be responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and quality audits that may impact Regeneron operations and / or product.
A typical day might include, but is not limited to, the following :
Maintaining professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.
g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.)
Supervising industry trends with respect to regulatory agency findings, expectations and warning letters
Performing supplier / external audits and evaluating systems, processes, procedures and records against applicable GxPs and audit criteria
Collaborating with procurement, external manufacturing, quality, audit clients and other stakeholders with respect to supplier / external audits
Performing and maintaining all required training and annual GMP training within required timelines
Performing required lead auditor or support auditor activities as applicable for assigned audits
Preparing written audit reports and documents in accordance with company and department procedures and requirements; ensuring the quality and accuracy of all audit documentation;
ensuring timelines for assigned audits are met
Providing guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards
Completing peer reviews of audit documentation and auditee responses; ensuring requirements for audit documentation and auditee responses are met
Participating in IOPS inspection readiness, inspections / partner audits, and internal audits as needed
Note this position requires approximately 50% travel, globally
This role might be for you if :
You have the ability to maintain integrity and honesty at all times
You have the ability to work independently or as part of a team
You have the ability to communicate with transparency
You have previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits
You have experience in understanding and interpreting regulatory guidelines and documents
To be considered for this opportunity you must have a BS / BA with 5+ years of related experience in Biotech / Pharmaceutical industry.
A minimum of 3 years of prior auditing experience in a GMP environment; experience in aseptic filling operations and supplier auditing is preferred.
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