Quality Systems Specialist
RK22464
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 who is looking to join a leading multinational who are one of the best at what they do.

Duties:

• Act as Quality SME for Process, Cleaning, Water, Equipment and Change Control systems.
• Lead validation activities and serve on site committees (PVC, CVG, WVC, EQVC).
• Oversee laboratory QA activities including incidents, stability reports, GLIMS and microbiology liaison.
• Manage critical systems including Annual Product Reviews, Quality Agreements, Supplier Change Evaluations, and Returned Goods.
• Approve validation documentation, participate in regulatory inspections, and ensure filing/licence maintenance.
• Maintain the integrity of site documentation for regulatory submissions and product filings.
• Drive GMP compliance and continuous improvement initiatives through internal audits and cross-functional collaboration.

• Degree or post-graduate qualification in Science, Pharmacy or Engineering field
• 3+ years’ experience, ideally in Quality within the Biological and/or pharmaceutical industry.
• Demonstrated experience with Change Control, Equipment/Process Validation, Laboratory QA, and System Ownership.
• Familiarity with SAP, GLIMS, and document control systems.