LSC have a great contract opportunity for a Quality Operations Specialist to join a leading biotech company based in Meath.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations.
- Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
- QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility.
- Review/Approval of validation/qualification/verification protocols and reports associated with new product or material entry.
- Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
- Responsibility for adhering to domestic and international GMP regulations, cGMP's, company policies, leadership behaviours, and performance and budget management.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- 4+ years' experience in QA.
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Grainne Hodnett at 021 4777 329 if you have any more questions about this opportunity!
