LSC has an exciting opportunity for a QA Rep 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Quality oversight of and guidance for SM on capital projects
- Maintenance of all aspects of GMP compliance for the area(s) of responsibility
- Establishment, maintenance, and management of a control system for the specific Quality System(s)/Program
- Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program
- Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program
- Review and approval of change controls and failure investigations, associated with the area(s) of responsibility.
Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
- Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc, MSc, in Chemistry, Engineering or related discipline.
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!
Call Grainne Hodnett at LSC on 021 4777 329 to discuss in detail or apply directly via this advert.