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Bio-pharmaceutical company based in Dublin is hiring for a Senior QA Specialist. The successful candidate will be responsible for the Quality oversight processes and procedures related to Packaging Technology Transfer/NPI, Validation and Engineering.
- Quality review and approval of Transfer, Validation and qualification documentation and SOPs to support site validation activities .
- Quality Review and approval of MBRs and BOMs.
- Perform all activities in compliance with Amgen safety standards and SOPs
- Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA record.
- University degree. Science or engineering related discipline preferred.
- Relevant experience (5 years +) working in the pharmaceutical or biotechnology industry providing quality direction for NPI/ technology transfer / packaging projects.
- Knowledge of devices/combination products regulations.
- Ability to work independently and remotely with minimum direct supervision.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com. #J-18808-Ljbffr