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. Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
- 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.
- Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
- Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
- Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
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!
