● GxP-Compliant Test Strategy & Leadership: Defined, implemented, and governed the overarching test strategy for validated GxP systems, ensuring full compliance with FDA 21 CFR Part 11 and other relevant regulations. Led and mentored a team of test engineers in GxP-aligned methodologies, ensuring adherence to strict quality standards. ● Validation & Test Automation: Architected, developed, and validated a scalable test automation framework for web and mobile applications, following GAMP 5 categories for software tools. Managed the formal validation of the test framework itself, including creation of Requirements Traceability Matrices (RTM) and Validation Summary Reports. ● Quality Management System (QMS) Integration: Established and standardized end-to-end QA processes integrated with the company's QMS. Managed all test artifacts—including Test Plans, Test Cases, and Defects—within Azure DevOps, enforcing electronic signature workflows and ensuring full audit readiness for internal and regulatory inspections. ● Stakeholder & Audit Management: Served as the primary quality representative for software validation during internal audits and regulatory inspections. Effectively communicated validation strategies, test outcomes, and risk-based testing approaches to cross-functional stakeholders and senior management. ● Risk-Based Testing & Compliance: Developed and implemented a risk-based testing methodology for computerized systems, prioritizing testing efforts based on patient safety and data integrity risks. Created and maintained all required documentation for the System Development Life Cycle (SDLC). ● Change & Incident Management: Governed the change control process for all test environment and tooling modifications, ensuring proper assessment, testing, and documentation. Led the investigation and resolution of critical deviations and incidents related to GxP systems, performing robust root cause analysis.

● Led and mentored a team of 5 software testers. ● Designed and implemented a unified test automation framework for web and mobile (iOS/Android). ● Developed master test strategies, plans, and QA processes from conception to execution. ● Managed test resources and collaborated cross-functionally to ensure milestone achievement. ● Utilized Azure DevOps for test case management, bug tracking, and project coordination.

● Developed a Test-Driven Development (TDD) automation framework using Java. ● Championed in-sprint automation by collaborating closely with developers. ● Managed the testing lifecycle using Jira for defect tracking and ALM for requirements. ● Led training initiatives for colleagues, customers, and partners, creating a comprehensive training strategy. ● Supported business operations through incident, problem, change, and release management processes. ● Engaged directly with clients to align on requirements and project goals.

● Creating a Testing Automation Process. ● Creating an Automation Framework and scripts Using Java. ● Creating Manual Test cases, Executing and defect logging. ● Creating automation scripts for back-end API.

● Creating Manual Test cases, Executing and defect logging. ● Writing Automation Scripts using JAVA. ● Creating automation scripts for back-end Test cases.