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Validation Analyst - County Tipperary, Ireland - Test Triangle
Description
Job DescriptionRole: Validation Analyst
Employment Type- TP
Location – Ballydine, 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.