Varshini Madaka Email & Phone Number

Varshini possesses a distinctive Combination of Technical and Quality expertise. She is a diligent, keen to detailed and results oriented Computer System Validation (CSV) and Equipment Qualification Specialist with 8+ years of experience in validation and verification of IT systems and Medical Devices in Life Science Industry with focus on IT Quality and compliance regulations. She has extensive experience in implementing the Quality Management System (QMS) services, providing automated solutions and data Visualization using power BI and Execl to minimize the manual efforts, Test strategy techniques with highest quality to the pharmaceutical clients at global level.Specifications:Technical Skills : Created an automated solution to enable the hassle-free business process for PMO activities using Microsoft Info Path, SharePoint designer, Power Apps, Power BI , Visio and MS Flows.Validation: Specialist in developing the validation strategies and reviewing, updating, and authoring the validation deliverables like – Validation Plan, Requirements (User and Functional), Risk Assessments, Test Protocols, Test Scripts (SAT, IQ, OQ and PQ), Gap assessment, Defect/Incident Reports, Data Migration, Validation Summary Reports of both IT Quality systems and Medical Devices.Verification:She has Good experience in executing the Test Cases and Test Scripts manually including end-to-end Testing, Data Verification Testing, Regression Testing, Integration Testing, Performance Testing and User Acceptance Testing (UAT)QMS Activities: Extensive experience in Change Management activities from creation and review of Change Control records (RFC’s) to the change implementation and providing SME support from IT Quality and compliance standpoint to the implementation teams. Implementing the end-to-end Document Management procedures starting from creation of a document in the Doc Management system (EDMS) to its approval and retention to imply with 21 CFR Part 11 regulations.  Performing Periodic reviews and base business reviews for the Quality System documents pertaining to systems (Validation Deliverables) and organization.  Specialist in LMS management supporting diversified client base, providing content creation, creating learning materials and ongoing program management activities.Skills:• FDA 21 CFR Part 11, Part 820• Annexure 11• GAMP 5• Quality Management System (QMS)• Change Management• Document Management• Project Management.• Microsoft Info Path, SharePoint designer, Power Apps, Power BI and MS Flows,Visio, SQL.