Operations Lead
14 hours ago
Operations Lead
12 Months
AS33864
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Ideally the person will have:
- Biopharmaceutical manufacturing experience in Fill Finish or related manufacturing.
- GMP experience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Duties:
- Function as the site interface between the Product Delivery Teams (PDT’s) and site Manufacturing operations.
- Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling, and Inspection.
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to 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.
- Provide troubleshooting support throughout the project and on the floor during execution of activities.
- Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation, and licences.
- Develop, review, and update Protocols for manufacturing activities.
- Document and approve 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.
- Develop, review, and update Product Quality Risk Assessments.
Education and Experience:
- 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.
If interested in this posting please feel free to contact Avishek Singh at Avishek.singh@lifescience.ie or 0872827991 for further information.
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