Music, Acting, Mimicry
15+ years of experience in Quality Assurance, Computer System Validation (CSV), Audits, Testing, and Project Management.
- Expertise in validating computerized systems as per GxP guidelines, ensuring compliance with regulatory standards (FDA 21 CFR Part 11, EU Annex 11).
- Proficient in SDLC, STLC, and test management tools (JIRA, ClearQuest).
- Skilled in drafting and executing validation documents (URS, FRS, IQ/OQ/PQ, RTM, VMP).
- Strong leadership and team management experience, with a focus on delivering high-quality results in IT, clinical, manufacturing, and quality software systems.
Led validation and testing efforts for IT and manufacturing systems, ensuring compliance with regulatory standards.
- Developed and executed test protocols (IQ, OQ, PQ) for software and hardware systems.
- Mentored and managed teams, ensuring timely delivery of high-quality validation deliverables.
- Collaborated with cross-functional teams to implement continuous improvement initiatives.
Vista Infotech Pvt Ltd | July 2004 – November 2007
- Managed testing activities for software applications, including functional, regression, and integration testing.
- Developed test documentation (test cases, scripts, and reports) and ensured adherence to project timelines.
- Conducted user acceptance testing (UAT) and provided support for system deployments
Validating Computerized Systems
SDLC
STLC
Bug Life Cycle
Bug Reporting
Test Documentation
UI testing
Functional Testing
Regression Testing
Sanity Testing
Usability Testing
Smoke Testing
Component Testing
Integration Testing
End-To-End Testing
Compatibility Testing
UAT
Black Box Testing Techniques
Mentoring
Leading
Managing
Validation Plan
Validation Summary report
undefinedGAMP 5 Certification* - *ISTQB Certified Tester
Music, Acting, Mimicry
GAMP 5 Certification* - *ISTQB Certified Tester