Senior Technical Lead |HCL America, Inc. | Tucson, Arizona, United States

Experienced in Systems V&V (Verification and Validation, CSV, System & software requirements , DHF remediation ,risk management.

15 Years of experience in Medical Device Testing , CSV in both Infrastructure and Application validation in Life Sciences/Pharmaceutical Domain, Functional Testing, Quality Assurance, Verification and Validation Testing,

• Worked on projects for major Pharma and Medical clients like Johnson & Johnson Vision, Abbott Medical Optics, Phase Forward (Oracle), AstraZeneca ,Roche, Genzyme, Genentech and Pfizer.
• Proficient in software testing with the Manual and Embedded testing.
  Expertise in using ALM, Quality Centre 9.2, for executing test cases and reporting the bugs.
• Worked on Agile Methodology and Waterfall Methodology
• Expertise in preparing Installation Qualification, Operational Qualification and Performance Qualification documents by thoroughly understanding the application.
• Proficient in drafting/authoring System/Functional/UAT test cases by thoroughly understanding the application.
• Proficient in Tool Validation (CSV).
• Expertise in preparation of Test Summary Report and Validation Summary Report.
• Expertise in creation of System Variance Report (SVR)/Deviation Report and Amendment Reports.