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Company NNIT Switzerland AG
in Basel
24.06.2025 Updated on: 24.06.2025
The Computer System Validation (CSV) Lead ensures compliance with regulatory requirements through the validation of computer systems in the pharmaceutical industry. Responsibilities include planning, coordinating, and executing validation activities for software and computerized systems used in drug manufacturing, laboratory operations, and quality management. Key Responsibilities:Develop and implement validation strategies according to regulatory guidelines (e.g., FDA, EMA, GxP).Create and maintain validation documentation (Validation Master Plans, User Requirements Specifications, Risk Assessments, Protocols, etc.).Lead validation activities including IQ/OQ/PQ phases.Conduct risk assessments and impact analyses for validation projects.Manage project timelines, resources, and budgets.Comm...
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