LSC have a great contract opportunity for an Operations Lead to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Function as the site interface between the Product Delivery Teams (PDT's), and Manufacturing operations.
- Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection
- Develop, review and update Production, Engineering, Operating Procedures & training materials
- Documentation and approval of protocol deviations for manufacturing activities
- Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner
- Own and lead change controls as required by the Manufacturing support team
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in a science discipline.
- 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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 Adam Murphy on 021 4777329 if you have anymore questions about this role!
