- Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
- Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
- Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
- Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release.
- Degree qualification (Science/Quality/Technical).
- 8-10 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
- Project Manager capability with significant understanding of Operations.
- Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- Experience in quality management systems such as Veeva, SAP, PAS-X etc.
