Job Description
Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will be involved in the biggest and best projects in Ireland and elsewhere. We offer excellent benefits and long term assignments. We are looking for a QA Validation Specialist to join our dynamic and innovative OTS team, working on a client site in Cork. The role is responsible for the execution, review and approval of validation activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment. The successful candidate will work closely with the Engineering team on document review and act as QA SME for capital projects. Please apply here and we will be in touch to discuss your experience as soon as possible. We look forward to partnering with you for continued professional success. Responsibilities To work within a live API Bulk plant production environment supporting the following tasks; Day-to-day projects / process improvement initiatives Supporting validation documentation / change control workflow through various stages of project lifecycle Ensuring validation documents are fit for purpose and contain the relevant information Reviewing engineering documentation to ensure compliance with QA and site standards and FDA/HPRA regulations Work with the Engineering Department, to ensure that all proposed projects have all required documentation in place, and that it is audit-ready by the QA Team onsite Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.) Working as a seconded PM Group resource in a client-led team To lead and/or support validation projects and activities on site, as directed and as appropriate To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan Commissioning and validation of various new technologies and new equipment Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits Ensuring manufacturing equipment is qualified in line with production schedule requirements Developing and writing validation procedures according to cGMP and regulatory requirements Generating and executing validation documentation Providing continuous improvement for existing validation procedures. Qualifications Degree qualified in Science or Engineering Minimum 5 years' experience in a similar role Strong Quality Assurance and Regulatory/Compliance experience in a pharma or medical device setting Experience of process and equipment validation on multiple projects Excellent attention to detail, a can-do attitude and strong communication skills Successful candidates will be able to demonstrate technical competence, will be able to work efficiently and safely, and will be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable Excellent interpersonal skills with ability to communicate to all levels i.e operators up to management #LI-AM2