I have over 12 years of experience in the field of Computer System Validation and software testing, in the Medical Devices, Healthcare and Life Sciences domains. I have executed projects based on GAMP 5 in adherence with 21 CFR Part 11, with expertise in the Validation process, Regulatory and Risk assessment, business and functional requirement analysis, comprehensive test scenario creation and test execution. I acted as a lead QA tester on development projects for MES system for the pharmaceutical/Biotech/Life Science industry clients. In my position as a consultant, I supervised a five-member software QA testing team in developing and implementing quality-assurance and quality-control methodologies to ensure compliance with QA standards, federal regulations and customer specifications. Key Skills: o Performed a gap analysis identifying significant documentation inadequacies. o Verifying that system requirements are clear, testable and consistent. o Validated systems used for Good Manufacturing Practices and Non-GMP o Implemented GAMP 5 Risk Based Approach Validation Framework and QMS checklist. o Authored, reviewed and approved Computer System validation CSV deliverables like • Project and Quality Executions Plan (QPEP) • Functional Risk Assessment • Validation Project Plan or Overall Test Plan • Configuration Management Plan- Configuration Item List, Migration plan, Technical Installation Plan • Standard Operating Procedures- Design Review Procedure, Design Review Report, Good Documentation Practices • Code Review Plan, Code Review Report, Design Specification • Traceability Matrix, Design Qualification • Validation Protocol Installation Qualification/ Operational Qualification documentation • Software Factory Acceptance Test, User Acceptance Test, • Validation Summary Report, Periodic Review Report, Verification Qualification Assessment • System verification with 21 CFR Part 11- Data integrity on Audit trail, Logical securities and user privileges o Experts in handling on various Testing philosophy –Installation Testing, GUI Testing, Functional Testing, Regression Testing, Integration Testing, Web base Testing, Factory acceptance Testing and User Acceptance Testing. o Validation expert on o provide integrated solution on Manufacturing Execution System modules i.e. Equipment, Inventory, Enterprise Resource Planning order and Equipment Workflows, Material Management, Document Control & Archiving and Reports. o Create, Execute and Test on various Equipment Process recipes workflows like clean/Autoclaved, Part Washer, Sterile Plate check, Ambient Thaw Material etc. o Interface testing of MES system in communication with Automation system, LIMS and ERP system o Conduct training for project team to impart knowladge on quality. o Installation Testing- • Perform BCSS file compare between Test environment and Dev environment and generate installation file listing. • Distribution package only file listing package to customer to avoid shortcoming