Validation Analyst

  • Dunboyne
  • Test Triangle
Job Description Role: Validation Analyst   Employment Type- TP   Location – Dunboyne, Ireland     Primary & Secondary Skill  Validation Analyst / Computer System Validation (CSV) JD (Detailed)    Preferred Skills: • Minimum 3-5 years’ experience in the Pharmaceutical industry or a similar operating environment, with a strong emphasis on Lab Systems. • Previous experience as a validation engineer or in a similar role • Strong understanding of manufacturing processes and safety regulations • Extensive experience in equipment calibration, performance testing, and quality control. • Experience in IT related documentation process (IQ/OQ & SDLC) • Prior QC Lab experience with analytical instrumentation qualification and system implementation. • Excellent written and verbal communication skills to effectively communicate with technical and business users. • Experience with working in a multinational organization.    Job Roles/Responsibilities:  • The Delivery Lead will act as a bridge between business challenges and technology solutions will work under leadership of the Site IT and will maintain a close relationship with a network of Global Infrastructure Operations and Support teams in Site IT as well as the operational teams at the site. • The Lab IT Lead will focus on planning and execution of Quality & Laboratory information systems projects including the building, configuration, qualification and validation of servers and PC’s for use in a GxP environment according to GAMP 5 and CFR 21 • Additionally, the Lab IT Lead  will assure full and continuous compliancy with regulatory and company requirements, for example CSV and SDLC. • Support the review & approval of key quality deliverables including SDLC, Change control, Deviations, CAPAs.  Etc.  • Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required. • Good at customer handling and liaising with all stakeholders.