- Perform all activities in compliance with safety standards and SOPs.
- Write, review and approve Standard Operating Procedures in accordance with Policies.
- Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
- Review and approval of deviations for closure ensuring compliance with appropriate documentation.
- Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
- Support continuous improvement and Operational Excellence initiatives.
- University degree. Engineering or Science related discipline preferred.
- Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
- Experience working in aseptic operations, protein formulation, vial, and syringe filling.
