Your new company
Here in Hays Recruitment, our Multinational Biopharmaceutical client in Cork is hiring a QA Specialist III.The successful candidate will be required to perform QA approval and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations within the GSIUC QA Department under the QA packaging and labelling support team.
Your new role
1. Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
2. Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
3. Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
4. Performs QA review and release of primary and secondary packaging components.
5. Performs QA review and approval of artwork.
6. Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
7. QA Review and approval of GMP Deviation investigations and CAPAs
What you'll need to succeed
8. Prior experience in the pharmaceutical industry is preferred (ideally within a QA role).
9. 4+ years of relevant experience in a GMP environment related field and a BS
10. 3+ years of relevant experience and an MS
11. Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs).
12. Demonstrates proficiency in application of QA principles, concepts, industry practices and standards.
13. Demonstrates working knowledge of FDA / EMEA standards and quality systems.
14. Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.