Senior Engineer - Qualitest - Bangalore
(2022-12)
Responsible for Validation activities in Veeva QMS and Veeva Quality Docs built on the Veeva Vault platform which includes the capabilities specific to the management of global quality process and facilitates managing the documents for medical information inquiries.
- Led Validation testing, Integration testing and Regression testing of enhancement requirements in Veeva Quality Docs and Veeva QMS
- Supported end-to-end delivery of Validation testing activities which include Planning, Documentation, Execution, and Closure
- Created and maintained validation documents for Veeva Releases including Validation Plans/Reports, User Requirements Specification, RTM and Validation Summary Report
- Collaborated with cross-functional teams to gather requirements and understand the configuration and design of Veeva Quality Management system workflows, lifecycles, document types, security settings, creation of DAC and Permission Sets
- Created and managed Change Controls, Change Actions, Deviation, RCAs, CAPAs along with Validation Impact Assessment
- Contributed to the revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards
Lead Consultant - Genpact - Bangalore
(2020-01 - 2022-11)
Ensure Computer System Validation for Pharma Co-Vigilance Artificial Intelligence (PVAI) product designed to support Global Case Management and Regulatory Reporting requirements integrated with Oracle Argus Safety tool for Automated Case Processing, Case Verification, Case Promotion to Argus, Case Processing and Reporting.
- Participated in Scrum Meetings to analyze and prioritize the User Stories from Sprint Backlog
- Involved in Validation testing of PVAI Product and compliance with 21 CFR Part 11 and GxP requirements
- Conducted Integration testing of PVAI with Oracle Argus Safety for Case Creation, Case Processing and Reporting
- Created and reviewed Validation Plan, RTM and Validation Summary Report
- Managed defects in JIRA and prepared weekly status reports highlighting project risks
- Represented Validation team in Sprint Planning meetings and Retrospections
- Involved in Test Case Optimization and Test Suite update for Regression
- Educated and trained project team on PVAI and Product Testing
Consultant - Capgemini - Bangalore
(2019-05 - 2020-01)
Spearheaded team to validate Learning Management System (LMS) Application from Cornerstone- SUMMIT (built on CSOD Platform), the training assignment workflows, curricula mapping and role-based access. Collaborated with Business and Vendor teams to analyze the requirements, design and execute test cases.
- Led end-to-end testing of SUMMIT LMS application across all STLC phases from Requirement analysis through test closure ensuring on-time delivery of the project
- Designed and reviewed test cases covering functional, integration, regression and UAT
- Handled Defect Lifecycle from creation to closure, analyzing the defects with root cause and prioritization
- Supported automation of test cases accelerating regression coverage
- Drove UAT co-ordination by creating test scenarios with Business users through demo sessions
- Conducted weekly status calls with leadership presenting key metrics with go/no-go decisions
Associate - Cognizant - Chennai
(2014-03 - 2019-05)
Worked on multiple projects involving testing and validation activities for Life Sciences and Insurance domains.
- Project 1 (May 2016 to 2019): Worked for SUMMIT project (LMS Application) as functional tester. Involved in STLC and Defect Management Lifecycle. Other project-related activities include attending SCRUM meetings with Test Lead and providing input in preparing test artifacts such as OQ Protocols, RTM and Test Summary Reports
- Participated in Scrum meetings to understand the functional requirements
- Attended client webinars and walkthrough sessions
- Authored and executed OQ, Supported PQ, Summary Report and Defect logging in HP ALM
- Performing dry runs to ensure minimal formal execution defects
- Coordinated with CSV teams for review and approval of test cases
- Project 2 (Mar 2014 to May 2016): Part of testing team to test an insurance web application- TIAA Brokerage which provides the capability to create TIAA managed Brokerage and Retirement Accounts, make Investments in Mutual Funds and ETFs to end users
- Involved in Test Case Design and Test Execution phases of STLC
- Reviewed the Test Cases, Test Plan, Test Strategy to understand Test documentation
- Attended webinars and domain knowledge transition sessions at Insurance Account by leaders
