Job Description:
We are seeking a Senior Operation Lead in the South Dublin Region for a Bio Pharma company. The Operations Lead will serve as the primary production process owner, overseeing New Product Introduction, Life Cycle Management Projects, CAPEX projects, and established process improvement initiatives. This role demands in-depth technical and operational expertise in aseptic drug product manufacturing processes, including parts/components preparation, formulation, syringe filling, vial filling, lyophilization, and capping.
Key Responsibilities:
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Interface Management: Act as the primary site liaison between Product Delivery Teams and ADL Manufacturing operations, ensuring effective communication and collaboration across departments such as Facilities & Engineering, Quality, and Supply Chain.
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Documentation Oversight: Develop, review, and approve Generic Master Batch Records, Parameter Value Lists, and Operating Procedures, ensuring all documentation meets GMP standards.
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Training and Support: Provide training on scientific and technical aspects of processes and projects to Direct Manufacturing, while also supporting scheduling and execution of Characterization, Engineering, and PPQ runs.
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Process Improvement: Evaluate and implement solutions for process improvement opportunities, troubleshoot issues during project execution, and conduct Job Hazard and Change Control Assessments.
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Change Control Leadership: Own and lead change controls, ensuring timely consultation with relevant stakeholders and adherence to SOPs, batch documentation, and GMP standards.
Key Requirements:
- Bachelor's degree in a science discipline.
- 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMPexperience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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