Sr.Business Analyst/Lead Validation (Pharma/IT)
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Computer System Validation CSV) consultant with 13 years’ experience in regulated pharmaceutical and IT services in life sciencesdomain. Expertise across CSV lifecycle URS/FRS/SRS, lQ/OQ/PQ), risk-based testing, test management and audit readiness. Hands on with GxP regulations FDA 21 CFR Part 11, EU GMP Annex 11), GAMP5 and data integritypractices.
Proven in standardizing CSVtemplates, leading validation for integrations and digitalizing compliance workflows using ServiceNow, HP ALM, Val Genesis tool and ADO. Targeting CSV Specialist or Validation Manager roles.
Computer System Validation CSV) consultant with 13 years’ experience in regulated pharmaceutical and IT services in life sciencesdomain. Expertise across CSV lifecycle URS/FRS/SRS, lQ/OQ/PQ), risk-based testing, test management and audit readiness. Hands on with GxP regulations FDA 21 CFR Part 11, EU GMP Annex 11), GAMP5 and data integritypractices.
Proven in standardizing CSVtemplates, leading validation for integrations and digitalizing compliance workflows using ServiceNow, HP ALM, Val Genesis tool and ADO. Targeting CSV Specialist or Validation Manager roles.
B. Tech (Electronics & Instrumentation Engineering) Passed in 2012 from JNTU-Anantapur, Andhra Pradesh – INDIA.
