Quality Assurance is critical to our success as a pharmaceutical organization. We are seeking an experienced Quality Systems Specialist to support our operations in Tipperary.
The Role Overview
The successful candidate will be responsible for overseeing the Quality Systems activities in both Drug Substance and Drug Product facilities. This includes:
1. Completing sub-system responsibilities per site System Ownership List.
2. Driving Quality performance metrics and continuous improvement within owned systems.
3. Serving as Quality SME for validation across Drug Substance and Drug Product operations.
4. Participating in committees related to quality management, such as PVC, WVC, CVG, and EQVC.
5. Approving validation documentation and supporting capital projects.
6. Maintaining validated state post-change; developing summary reports and quality plans.
7. Being the Principal Quality contact for all site change requests affecting processing.
8. Conducting full lifecycle reviews for change controls and material strategy assessments.
9. Providing QA oversight for laboratory systems, documentation, and incidents.
10. Approving stability reports and supporting OOS investigations.
11. Acting as the Microbiology QA Point of Contact for water, utilities, environment, and product-related issues.
12. Owning and maintaining the Site Master File, Validation Master Plan, and key procedures.
13. Overseeing Annual Review and Quality Agreement systems.
14. Approving user access reviews and site application controls.
15. Participating in internal audits, customer complaints, and supplier change evaluations.
16. Supporting site regulatory inspections and license/filing documentation requests.
17. Managing returned goods disposition in line with quality requirements.
18. Leading scheduling, minutes, and follow-ups for monthly Quality Council meetings.
19. Actively promoting GMP awareness and continuous improvement site-wide.
This is an excellent opportunity to join a leading multinational company and contribute to our success.