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Quality Systems Specialist
RK23300
Contract – 11 months
Tipperary
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone looking to join a leading multinational known for excellence in the industry.
The role requires the specialist to support the Quality Systems activities in both the Drug Substance and Drug Product facilities.
Duties:
1. Complete sub-system responsibilities per site System Ownership List.
2. Drive Quality performance metrics and continuous improvement within owned systems.
3. Serve as Quality SME for validation across Drug Substance and Drug Product operations.
4. Participate in PVC, WVC, CVG, and EQVC committees.
5. Approve validation documentation and support capital projects.
6. Maintain validated state post-change; develop summary reports and quality plans.
7. Principal Quality contact for all site change requests affecting processing.
8. Conduct full lifecycle reviews for change controls and material strategy assessments.
9. Provide QA oversight for laboratory systems, documentation, and incidents.
10. Approve stability reports and support OOS investigations.
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