CSV Engineer – Senior Contract (Full Time) Cork – Ireland

Job Listing No: 9740000

CSV Engineer – Senior Contract (Full Time) Cork – Ireland

Cork – POSITION SUMMARY: Min 3 years of experience in CSV system development life cycle is required. GENERAL SCOPE OF RESPONSIBILITIES: Responsible for developing a process for and performing of validation of computer and/or automation systems compliance current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11. QUALIFICATIONS AND EXPERIENCE: Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements. Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology. Keeps systems and processes developed for computer and automation systems validation up to date and compliant. Gives guidance on all activities related to computer and automation systems validation. Support activities include, but are not limited to, SOP creation, documentation review and approval Inc… – Permanent – Full-time

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