CSV Lead

3 weeks ago


Ohio City, United States Tata Consultancy Services Full time
  • Expertise in conducting Risk Assessment, ensuring compliance to Part 11, 820, GAMP guidelines, Security Assessment, Corrective and Preventive Actions (CAPA) Investigation, GxP (cGMP, GDP, GCP, GLP) suites and Standard Operating Procedures (SOP).
  • Expertise in Developing and reviewing SDLC deliverables including Validation Master Plan (VMP), Requirement Specifications (URS/ FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Protocols, Requirements Traceability Matrix (RTM), Reports and Validation Summary Reports (VSR).
  • Experience in Periodic Review, GAP Analysis, Risk analysis, CAPAs and Remediation Process.
  • Experience with end-to-end CSV/Validation process delivery.
  • Excellent analytical and documentation skills.
  • Customer facing experienceGood communication skills

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