Quality Systems Specialist RK22464 Contract 11 months Tipperary Were 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.
Experience and Education: 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.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Skills: Quality Systems Auditing Technical report writing