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About
Nice to Haves: If they come from Catalent
One Liner on the role: This Person will be leading cGMP QA Compliance Activities. You will overseeing all the qa aspects of equipment. You will be working with external outsourcing partners to make sure they are doing the right stuff in regards to Capa. Will be inputting and maintain knowledge of the FAS regulations that you are upholding
Job Description: Our biotech client seeking a highly motivated individual to join their team as a Sr. Specialist in the Quality Assurance (QA) department reporting to the Sr. Director of External Quality Operations. This position will be responsible for ensuring quality of cGMP activities at external contract organizations (CxOs) for aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of internal and external partners.
Responsibilities: • Lead cGMP QA compliance activities at external CxOs for all relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products • Oversee quality aspects for commissioning, qualification and validation activities for equipment, batch record review, deviation handling and quality event processes at external CxOs • Support complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, when applicable • Liaise with external QA representatives and maintain external relationships • Maintain knowledge of current industry standards and trends in best practices for compliance with cGMP regulations
Minimum Requirements: • Life Sciences-based BSc or advanced degree with a minimum of 5 years' experience in pharma, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment • Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy • Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations • bility to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts • Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity • Experience working with CxOs and contract testing labs preferred • bility and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)
Languages
- English
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