Csq Engineer

CareerWise Recruitment

Waterford

CSQ Engineer required by CareerWise Recruitment for our multinational biotech client in County Waterford for 12-month contract. The position being advertised is an exciting and challenging CSQ Engineer role with a focus on Computer Systems Validation. THE ROLE: * Prepare a local validation protocol and report. * UAT (User Acceptance Testing) plan to verify that the system performs as expected in its local environment including (but not limited to) software function, end-to-end process flows, user training adequacy, local procedures fitness for purpose, load/stress performance testing, exception case testing etc. * UAT prepared by and pre-approved and on completion by delegated Users the post approval to be completed as CSQ as final reviewer. * Local data migration verification - To supplement global migration testing documentation, use a sample of data (various means of verifying this including but not limited to record counts, record size counts, and direct record content comparison in the source and target/ QualiPSO systems. * Interface testing of global and any local interfaces not addressed by the upgrade, or any interface procedural work-arounds. * Updates to Computerised System inventory list. * Review Global validation materials (e.g. URS, GxP RA, VMP, Configuration Specs, Design Review, Installation Testing, Functional Testing, Release Testing, Automated testing tool assessments [ref. EU Annex 11], & Validation Report) to gain understanding of the global verification process to inform gaps in site validation strategy. * Review the relevant documentation as listed above from a CSV and Quality role under the title of Computer Systems Quality (CSQ) as part of the global project approval process. * Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.) * Participation in external regulatory inspections. REQUIREMENTS: * Relevant Engineering or Science qualification. Previous validation experience in sterile manufacturing, solid dose and devices would be highly advantageous for the role. * Experience, qualification or knowledge of Computer Systems Validation would be desirable. * Working knowledge of the CSV lifecycle model elements and requirements. * Awareness of GAMP 5 - A Risk-based Approach to Compliant GxP Computerised Systems. * Awareness of EudraLex GMP Annex 11 - Computerised Systems; FDA 21 CFR Part 11 - Electronic Records, Electronic Signatures, Final Rule. * Strong understanding of the CSV lifecycle model elements & requirements. Familiarity with GAMP 5, EU GMP Annex 11 - EudraLex Volume 4 - EU guidelines to Good Manufacturing Practice. Please call James Farrar today for further information on 0872489961 or email: jfarrar@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

394 days ago