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CSV Consultant
Job Description:
Job Summary:
Job Summary:
- CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
- The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
- Strong verbal and written communication skills
- Experience in the pharmaceutical, biotechnology, or medical device industry
- 2+ years of experience with System Development Lifecycle (SDLC)
- 3+ years of experience in Computer System Validation (CSV)
- Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
- Knowledge of FDA guidance and industry standards (e.g., GAMP)
- Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously
- Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports)
- Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications
- Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures
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