LSC have a great contract opportunity for a QA Manager 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 a minimum of 7 year experience in Quality Assurance and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide technical expertise for all QA and compliance topics / issues relating to Alexion manufacturing and product supply of drug product.
- Acts as quality point person, providing guidance and feedback on quality assurance issues.
- Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
- Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of 7-10 years relevant experience within the pharma industry or a related field.
- QP Qualified is desirable.
- Strong knowledge of cGMP requirements for pharmaceutical manufacturing required. 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 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 Pawel Jurkiewicz at LSC on 021-4777329 if you have anymore questions about this QA Manager role!