Our client, a leading pharmaceutical organisation based in South Dublin are recruiting for an Operations Lead for a long term contract role.
The Operations Lead will serve as the primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects.
* Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.
* Develop, review and approve generic 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 process/project
* Evaluate, plan, and implement solutions for process improvement opportunities
* Support scheduling and execution of Characterisation, Engineering and PPQ runs including 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
* Hold people to account for delivery and behaviours within Product team
* Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
* Partner with Learning & Performance to define training strategy's for NPI's and complex projects
* Liaise 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
* Documentation and approval of protocol deviations for manufacturing activities
* Liaise with Process Development regarding process changes in an effective and timely manner
* Own and lead change controls as required by the NPI Project Team
* Review and approve bills of materials
* Develop, review and update Product Quality Risk Assessments
* Bachelor's degree in a science discipline.
* 2+ 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.
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