Nanda Kishore Chauhan
Senior Validation | CSV | GxP | GAMP 5 | 21 CFR Part 11 | EU Annex 11 | LSMV | ARISg | ARGUS | DCT | eCOA | Medidata | Software Testing Pharmacovigilance (Drug Safety) and Clinical Trial Systems | Risk Assessment
- Role
- Senior Validation and Testing Analyst at Takeda
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Nanda Kishore Chauhan
Having 12+ years of experience in Computer system validation testing (CSV) and Pharmacovigilance drug safety applications – ARISg | LSMV | ARGUS | PVCM | PVR and clinical trial applications eCOA system EDC system.• Experience in Computer System Validation testing (CSV), Manual Testing with Software Development Life Cycle (SDLC) and Pharmacovigilance drug safety applications. • Clinical trial applications: Test plans, execution of test cases and test scripts. UAT is supported by electronic clinical outcome assessments (eCOAs) and EDC systems. • Good knowledge in Software Testing including Manual Testing using Black Box, Functional, Sanity, Build Acceptance, UAT Support and Regression. • Handled test management tools using HP ALM and Jira.• Experience of handling in defining Test protocol, Traceability Matrix, Pre/ Post Validation Summary Report (PVSR/VSR) and Compliance analysis, Pre/Post approving change requests and Bug/Defect log Tracking and reporting on Jira.• Experience in preparation of Validation Protocols IQ | OQ | PQ Test cases, execution reports.• Performing Risk Analysis (RA), GAP Analysis (GA), Risk Impact Assessment (RIA) and Root Cause Analysis (RCA) on process deviation.• In depth understanding of Good Pharmacovigilance Practices (GVP), GAMP5, GxP, 21 CFR Part 11, and EU Annex 11.
Experience
Senior Validation and Testing Analyst
Nov 2024 — Present · IN
Education
Bhaskara College Of Pharmacy
Master's degree, Pharmaceutical Sciences
2012 — 2014
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