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 021 4777329 if you have any more questions about this role!
