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CSV Engineer
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- Role: CSV Engineer
- The CSV Engineer collaborates with QA, IT, and business users to define user requirements and understand system functionality for computerized systems and data integrity.
- Ensures CGMP regulatory compliance by maintaining system functionality and conducting periodic reviews and remediation activities.
- Expertise in validation practices and regulatory requirements (e.g., 21CFR Part 11, EU Annex 11)
- Acts as a subject matter expert on computer validation lifecycle processes
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