SRG Ireland have partnered with a Pharma company based in South-Dublin looking to hire a Production Specialist.
Salary - €50-60K + Bens (Pension, Healthcare, Education Assistance + more)
On-site - South Dublin
Responsibilities:
1. Oversee operations, exclude calibration scheduling.
2. Monitor EMS, address anomalies.
3. Review batch documents.
4. Handle quality investigations and risk assessments.
5. Identify root causes in quality incidents.
6. Organise and maintain GMP documentation.
7. Manage Operations change controls.
8. Update training matrices and programs.
9. Perform Production and Warehouse Product Quality Reviews.
10. Regularly audit GMP and safety compliance.
11. Conduct Environmental, Health, and Safety Audits.
12. Report on Operations metrics and suggest enhancements.
13. Engage in improvement/compliance projects for better GMP and safety.
14. Train staff on cGMP documentation practices.
15. Attend operations meetings as needed by Plant Manager.
16. Represent operations in regulatory and internal audits.
Ideal candidate:
17. Highly familiar with QA methodologies
18. 2+ years' exp in a similar role
19. Regulated manufacturing experience (3+ years)
20. Experience in Quality Systems.
21. Technical Documentation exp.
22. Skilled in training staff on cGMP documentation.
23. Confident in representing operations during audits.