Leading global manufacturing organisation require a CSV specialist for a permanent role based at Cork site.
The Computer System Validation (CSV) Specialist helps to ensure Pharma Solution's compliance with company policies, procedures, and industry guidance. The CSV Specialist execute computer system validation test scripts, draft protocols and initiate and review GMP documentation revisions.
Responsibilities:
• Responsible for the validation of automated equipment and control systems.
• Initiate/update GxP and Risk Assessments of computerized systems.
• Create and modify validation documentation including but not limited to criticality assessments, validation plans, user requirement specifications, functional and design specifications, traceability matrices, and CSV protocols (IQ, OQ, PQ).
• Write reports which summarize the results of the protocol executions.
• Write exception reports which identify defects or issues during test execution.
• Review vendor documentation.
• Author System Release Memos and Validation Summary Reports.
• Conduct Audit Trails and Periodic Review of Computer and Automation systems.
Experience• Bachelor's degree required, preferred in computer science, engineering, or other sciences.
• Minimum of 2-3 years of experience working with automation and/or computerized system validations.
• Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.
• Experience working with EudraLex Volume 4 Part I, II and Annex 11, GAMP 5, and MHRA and WHO Guidance on Data Integrity would be an advantage
IT Site Lead for the Cork process plant and support functions with over 150 users.Part of a global flavors and fragrances business in over 60 countries worldwide.You will have responsibility for End-to-End IT Service Delivery including:Infrastr
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