Operations Excellence Technical Specialist Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years City: Cork State/Province: Cork Country: Ireland Job DescriptionAbout PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
A fantastic opportunity has arisen for an Operations Excellence Technical Specialist. The Technical Specialist will work on the Operations Excellence team, reviewing constraints in the current manufacturing process and delivering projects that directly combat these constraints.
RequirementsBring energy, knowledge, and innovation to carry out the following: Support the process by holistically reviewing how and why individual process steps are performed, identifying areas where efficiencies can be made, and leading projects to deliver these efficiencies.Manage EHS and Quality investigations and oversee batch record reviews.Provide technical support to Operation functions and changes.Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.Be 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.Ensure compliance with the highest standards for Quality and Safety.Ensure compliance with site EHS policy, cGMP, and other business regulations and lead/co-ordinate Technical IPT 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.What skills you will need: In order to excel in this role, you will more than likely have: 5+ years experience in a pharmaceutical or a highly regulated environment.B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering, or a related field.Project management experience in wide-scaled and/or complex projects.Strong analytical and problem-solving skills.
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