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Quality Systems Specialist
1 month ago
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. An opportunity exists for an experienced Quality Systems Specialist to support Quality Assurance and compliance functions within both Drug Substance and Drug Product manufacturing environments. Duties: Quality Systems Ownership: Lead and maintain assigned quality subsystems, ensuring compliance with internal policies and regulatory standards. Validation Subject Matter Expert: Act as the QA lead for process, cleaning, equipment, and water validation. Support validation committees, capital projects, and change management. Change Control & Laboratory Oversight: Review and approve quality-impacting change requests, laboratory investigations, instrumentation systems, and stability reports. Act as QA liaison for microbiology issues. Quality Documentation & Agreements: Create, review, and approve key site documents including the Site Master File, Validation Master Plan, and Quality Agreements. Annual Product Reviews & Quality Council: Coordinate the Annual Review process and manage the site Quality Council agenda and follow-ups. Regulatory & Audit Support: Support GMP audits, regulatory inspections, license maintenance, and documentation for filings. Supplier & Customer Complaints: Lead QA investigations into internal/external complaints and supplier change evaluations. Continuous Improvement: Participate in cross-functional projects and quality initiatives, ensuring alignment with GMP and best practices. Educational and Experience Degree (or higher) in Science, Pharmacy, or Engineering. Extensive knowledge of GMP, validation principles, quality systems, and pharmaceutical manufacturing processes. Proficient in problem-solving, technical writing, stakeholder communication, and system development lifecycle principles. Strong leadership, time management, and cross-functional collaboration skills. 4+ years experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. Experience in quality management systems such as Veeva, SAP, LIMs, Trackwise If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
