LSC have a great contract opportunity for a NPI QA Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Quality Oversight on new product introduction in Bulk Drug Substance facility. Site QA responsibility to provide technical expertise for all QA and compliance topics Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and others. Quality oversight on operations and technical services to review and approve Process descriptions, sampling plans, operational procedures, process validation and cleaning validation documents. Review and Approve TRA's, MSRs, SAP requests related to new products. ABOUT YOU - ARE YOUR SKILLS A MATCH? Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 5 years' experience in cGMP Quality environment; or equivalent combination of education and experience. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Kathy Gillen at LSC on if you have any more questions about this role! Skills: cGMP Delta-V TRA'S MSR's