A Senior Supplier QA Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will operate within the Supplier Quality team to support the qualification and post-qualification monitoring of GxP Suppliers. The incumbent will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the biopharma industry.
- Support the Global GxP Supplier approval and update processes.
- Support the Supplier Change Notification (SCN) process to ensure Supplier changes are reviewed and assigned to the appropriate owners.
- Support the Quality Agreement Management process.
- Support process performance projects as directed.
- Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
Qualifications & Experience:
- B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.
- Minimum of 7 years’ experience in Quality with medical device, pharmaceutical, or biologics experience.
- This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
- A good understanding of the concepts and systems applied to cGMP operations.
- The person will have experience with Technical Writing and Problem-Solving methods.
- Working knowledge of computer programs (Microsoft Word, Excel, PowerPoint).
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