CSV Engineer - Galway
Our client, a well-established IT company, are looking for a Computer System Validation (CSV) Engineer to join their expanding team. The role will be Galway based and will involve working in a GMP environment. Main responsibilities: Assisting and co-ordinating the qualification and validation processes of new and existing computerized systems. Handling all CSV related deviations, non-conformances and change controls. Formulating logs and information on current computer systems on site. Working on Validation Plans and Risk Assessments. Ensuring that computerised systems are in full compliance with regulatory requirements, company policies and procedures. Requirements: Level 8 degree in IT, Quality or a related discipline. GMP experience with basic QA knowledge within a regulated environment. Computer systems validation experience. Good documentation skills and attention to detail. Good knowledge of computerised system development life cycle. Good knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11. Interested? For immediate consideration call Greg on 051 878 813 or email your CV in response to this job posting. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. Hartley People Recruitment also recruit for similar roles such as IT Project Manager, Quality Control Manager, Production Support Analyst, desktop Support Analyst, Quality Assurance Manager, Validation / Process Engineer, New Product Development Manger, Quality Systems Manager, Process Engineering Graduate.
13 days ago