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 documentat...