Nikisha Shende
Test Manager @Qualitest
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WORK HISTORY
Test Manager @Qualitest
San Francisco, CA, US
EDUCATION
MCT's Rajiv Gandhi Institute Of Technology
Bachelor’s Degree, Computer Engineering
SKILLS
ABOUT NIKISHA SHENDE
QA & Validation Leader with 15+ years of experience in the Life Sciences industry, specializing in GxP compliance, Computer System Validation (CSV), and risk-based testing within regulated environments.Proven track record leading verification, validation, and quality assurance activities for complex computerized systems across clinical, quality, supply chain, and enterprise platforms. Extensive hands-on experience across the full validation lifecycle, including test planning, execution, defect management, traceability, and validation summary reporting.Expert in IQ/OQ/PQ and UAT development and review, supporting initiatives such as new system implementations, legacy remediation, data migration, periodic reviews, and system decommissioning. Deep understanding of SDLC methodologies, GAMP 5, 21 CFR Part 11.
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