Senior Test Lead - Embedded Software

Experience: Not Available to Not Available years

Location: Chennai, India

Skills: Veeva Vault QMS, QMS platforms, risk-based validation, Computer Software Assurance, SDLC, test management, system testing, integration testing, UAT, regression testing, GxP, GMP, GCP, GLP, 21 CFR Part 11, Annex 11, data integrity principles, JIRA, XRAY, Selenium, Testcomplete, C, Python, ISTQB Certified Tester Advanced Level, Certified Agile Tester

Job Summary
Validation and Testing Lead Extensive experience leading validation activities for multiple large-scale implementations of Veeva Vault QMS (or similar QMS platforms) within the life sciences / regulated lifecycle industry.
• Deep understanding of QMS business processes, including end-to-end Deviations, CAPA, Audits, and Inspections, and their implications for validation scope and risk.
• Strong expertise in risk-based validation and Computer Software Assurance (CSA) approaches, including definition of validation strategy, risk assessments, and criticality-based testing.
• Proven ability to design and develop overall validation strategies and plans (VMP, validation approach, scope, roles, timelines) aligned with regulatory expectations and project objectives.
• Hands-on experience with SDLC and test management across the full lifecycle: test strategy, test planning, test design, test execution oversight, and test closure.
• Strong test management skills, including management of system, integration, UAT, and regression testing, and ensuring robust requirements–test–defect traceability.
• Leadership experience managing and mentoring teams of Validation Analysts and Testers, including workload planning, quality oversight, and coaching on validation best practices.
• Expertise in defect management: establishing processes for defect logging, triage, prioritization, resolution tracking, and ensuring transparent communication across business and IT teams.
• Solid knowledge of GxP,



GMP/GCP/GLP, 21 CFR Part 11, Annex 11, and data integrity principles, with a track record of producing audit-ready validation documentation.
• Proficiency with JIRA, XRAY (or similar tools) and document management systems for managing validation deliverables, traceability matrices, test evidence, and status reporting.
• Strong stakeholder and governance skills, including collaboration with QA/Validation, Business, IT, and Vendors to agree on validation scope, resolve issues, and support inspections/audits.
• Excellent communication, analytical, and problem-solving skills, with the ability to challenge assumptions, manage risks, and drive consistent validation standards across all workstreams

Key Responsibilities
1. Engage In Functional And Technical Discussions With Clients And Team Members To Thoroughly Understand Functional And Design Specifications, Ensuring That Appropriate Test Environments And Infrastructures Are Maintained And Updated.
2. Identify Opportunities For Process Improvement In Functional Testing Methodologies And Tools, Implementing Best Practices To Enhance The Efficiency And Effectiveness Of The Testing Processes.
3. Oversee The Creation And Execution Of Automated Test Scripts Using Tools Like Selenium And Testcomplete, Ensuring They Meet Quality Standards And Minimize Exposure To Defects.
4. Develop, Guide, And Mentor Qa Engineers In Utilizing The Testing Framework, Fostering Their Technical Skills And Increasing Overall Productivity.

Skill Requirements
1. Advanced Proficiency In Functional Testing For Embedded Software.
2. Strong Understanding Of Testing Methodologies And Tools, Including Test Automation Frameworks.
3. Familiarity With Various Programming Languages Such As C And Python For Scripting Automated Tests.
4. Excellent Analytical Skills To Assess And Mitigate Performance Concerns And Inconsistencies.

Other Requirements
1. Optional But Valuable Certifications Include Istqb Certified Tester Advanced Level And Certified Agile Tester (Cat).

📌 Senior Test Lead Embedded Software (Chennai)
🏢 HCL Technologies
📍 Chennai