NPI QA Specialist, Dublin

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 Packaging 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!

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