Management of deviation and CAPA records will include:
- cross-functional collaboration to ensure the proper root cause and corrective actions have been identified
- ensuring the written report contains the technical merit and completeness according to regulatory expectations
- coaching customers on navigation within the deviation management electronic system
- Bachelor or Master s degree in Life Science or Engineering discipline.
- 3+ years of experience in execution and/or approval of deviation investigations.
- Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology / pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred.
- Experience in a Quality Assurance or technical MSAT role within a GMP manufacturing organization.
- Experience with using Root Cause Analysis (RCA) tools and methodologies.
- Experience with using Quality Risk Management principles.
- Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.