CSV Analyst Role with NTT DATA

NTT DATA seeks a CSV Analyst dedicated to maintaining GxP compliance in regulated systems. Work in the US timezone while ensuring detailed oversight and support for validated systems.

This position requires a detail-oriented professional with substantial experience. The CSV Analyst will author Validation Plans, conduct IQ/OQ/PQ activities, and drive risk assessments. You will also participate in audits, prepare compliance documentation, and oversee change management initiatives.

Key Responsibilities: • Author Validation Plans and User Requirement Specifications • Conduct comprehensive IQ/OQ/PQ activities • Prepare compliance documentation for audits • Drive risk assessments to uphold validation standards • Oversee validated systems change management

Requirements: • Bachelor’s degree in Computer Science or related area • 8 years of FDA-regulated CSV experience • 3 years focused on JD Edwards • Familiarity with GAMP 5 methodology • Strong documentation and coll...

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