LSC have a great contract opportunity for a QA Representative for Small Molecule Operations to join a leading Global Pharmaceutical company based in Cork.
If you have a BSc, MSc, or PhD in Chemistry, Engineering or related discipline, with minimum 1 year production/relevant experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
- Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
- Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
- Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA's.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience working in cross functional teams and proven ability in decision making.
- Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
- Demonstrates a continuous improvement mind-set.
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 Aoife Gleeson at LSC on 021-4777329 if you have anymore questions about this QA Rep opportunity!