Gmp Quality Auditor Job In Munster

Job Description

Within this role 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.
Note this position requires approximately 50% travel globally.

As a GMP Quality Auditor, a typical day might include, but is not limited to, the following:

1. Maintaining professional expertise and knowledge of audit criteria including 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.)
2. Supervising industry trends with respect to regulatory agency findings, expectations and warning letters
3. Performing supplier/external audits and evaluating systems, processes, procedures and records against applicable GxPs and audit criteria
4. Collaborating with Procurement, External Manufacturing, Quality, audit clients and other stakeholders with respect to supplier/external audits
5. Performing and maintaining all required training and annual GMP training within required timelines
6. Performing required lead auditor or support auditor activities as applicable for assigned audits
7. 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
8. Providing mentorship and support in the development of corrective and preventive actions based on GxP requirements and industry standards
9. Completing peer reviews of audit documentation and auditee responses; ensuring requirements for audit documentation and auditee responses are met
10. Participating in IOPS inspection readiness, inspections/partner audits, and internal audits as needed
11. Performing other duties and responsibilities as assigned by management

This role might be for you if:

1. You have the ability to maintain integrity and honesty at all times
2. You have the ability to work independently or as part of a team
3. You have the ability to communicate with transparency
4. You have previous experience as SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits
5. You have experience in understanding and interpreting regulatory guidelines and documents

To be considered for this opportunity you must have a BS/BA with 4+ years of related experience in the Biotech/Pharmaceutical industry. A minimum of 2 years of prior auditing experience in a GMP environment; experience in aseptic filling operations and supplier auditing is preferred.