Regulatory Compliance Expert
3 days ago
About the Position: We are looking for a skilled QC Chemist to join our client's team in Cork, Ireland.
Job Summary: The successful candidate will support testing of finished products, ensuring compliance with specifications and protocols, and participate in validation and commercial/developmental manufacturing activities.
Responsibilities:
- Review analytical data and documentation to ensure adherence to GMPs, GLPs, and regulatory requirements.
- Support reviews and investigations for out-of-trend/out-of-specification results.
- Participate in validation and commercial/developmental manufacturing activities.
- Troubleshoot standard instrumentation/test methods.
- Coordinate waste management, LEAN/Operational excellence, and 5S efforts.
Requirements:
- Bachelor's Degree (Level 8) in a relevant Science or technical discipline.
- 2+ years of experience in the pharmaceutical industry.
- Experience with chromatographic separations (UPLC/HPLC) and Empower.
- Working knowledge of GMPs, GLPs, and regulatory requirements for testing and validation.
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