Operations Excellence (Opex) Specialist

Summary:

Our client, a global biopharmaceutical company located in Cork, is seeking an Operations Excellence (OpEx) Specialist. The ideal candidate will work on the Operations Excellence team and be responsible for reviewing constraints in the current manufacturing process and delivering projects that directly combat these constraints.

Responsibilities: Support the process by reviewing the how and why individual process steps are performed, identifying areas where efficiencies can be made, and leading projects to deliver these efficiencies. Managing EHS and Quality investigations and overseeing batch record reviews. Provide technical support to Operation functions and changes. Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines. Responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols. Apply Lean Six Sigma and Lean methodologies. Represent the department on cross-functional project teams. Adherence to highest standards for Compliance (Quality and Safety). Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical input to risk assessments, audits, regulatory inspections and incident investigations. Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Qualifications & Experience: Bachelor's (Science) Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field. Minimum 5 years' experience in a pharmaceutical or a highly regulated environment. Project management experiences in wide-scaled and/or complex project.
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