LSC has an exciting opportunity for a APIEM-QA to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture.
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:
- Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.
- Provide quality oversight of CM method validation or method transfer activities
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.
- Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.
- Testing experience with Small Molecule
- Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
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 Cian Marnane at LSC on 021 4777329 if you have any more questions about this role!
