Nikisha Shende

Test Manager @Qualitest

Fremont, CA, US
MOBILE NUMBERS
+16•••••••63

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WORK HISTORY

May 2023 — Present

Test Manager @Qualitest

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San Francisco, CA, US

EDUCATION

N/A

MCT's Rajiv Gandhi Institute Of Technology

Bachelor’s Degree, Computer Engineering

SKILLS

Microsoft OfficeTest PlanningGxpTeamworkTeam ManagementTest ManagementManual TestingUser Acceptance TestingBugzillaOnsite-Offshore Co-OrdinationSoftware Development Life Cycle (Sdlc)Validation TestingDefect TrackingHp Quality CenterBlack Box TestingTest CasesFunctional TestingQuality AssuranceWeb TestingDefect Life CycleSerializationSystem TestingJiraRequirements AnalysisRegression TestingTestingOqMaster Data ManagementSqlTrack and TraceU.s. Title 21 Cfr Part 11 RegulationSoftware Testing Life Cycle

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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