Operations Lead 12 Months AS33864
This is an exciting opportunity to join a leading multinational pharmaceutical organization based in Dublin.
Ideal candidates will have biopharmaceutical manufacturing experience in Fill Finish or related manufacturing, or GMP experience in the pharmaceutical or medical device industry.
The role requires expertise in regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Duties:
* Act as the site interface between Product Delivery Teams (PDTs) 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 on 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 SOPs, batch documentation, and licenses.
* Develop, review, and update Protocols for manufacturing activities.
* 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.
* Develop, review, and update Product Quality Risk Assessments.
Requirements:
* 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.