Senior Product Specialist

Chennai, Tamil Nadu

Job Summary

- 10+ years in software testing, with strong experience in pharma/life sciences R&D;
- Strong understanding of GxP computerized systems and regulated testing (GAMP 5, Part 11, Annex 11)
- Experience testing Clinical Development / clinical data applications and complex data-driven systems
- Solid hands-on experience with JIRA + Xray for test management
- Strong test automation experience — Robot Framework + Python as the primary stack
- Experience with API, database/data validation, and integration testing
- Working knowledge of CI/CD and Jenkins
- Strong defect analysis, troubleshooting, and root-cause-analysis skills
- Demonstrated experience leading offshore test teams and coordinating with global/onshore stakeholders
- Strong grounding in risk-based testing, regression strategy, and automation strategy
- Exposure to AI-driven/GenAI or agentic testing solutions
- Experience with AI-assisted engineering tools (e.g., GitHub Copilot or equivalent)
- Tricentis Tosca experience (desirable, not mandatory — Robot Framework/Python is the primary stack)
- Exposure to cloud/data platforms (AWS, Databricks, or similar)

Key Responsibilities

- Lead end-to-end testing (functional, integration, regression, automated)



for GxP-regulated clinical/R&D; applications
- Create test strategy, planning, estimation, execution, defect management, and reporting across releases
- Review requirements and define risk-based test and regression coverage
- Manage requirements, test cases, executions, defects, and traceability in JIRA + Xray
- Drive and review automation using Robot Framework (Python), integrated with CI/CD (Jenkins)
- Ensure compliance with GxP, GAMP 5 (2nd Ed.), 21 CFR Part 11, EU Annex 11, and CSV/CSA practices
- Author validation deliverables — test evidence, traceability, deviations/defects, audit-ready documentation (ALCOA+)
- Analyze automation/regression failures and provide technical direction for remediation
- Coordinate an offshore test team — allocate work, track progress, manage risks/dependencies
- Define and track testing KPIs: automation coverage, regression coverage, defect trends, release quality
- Communicate status, risks, and recommendations clearly to onshore/client stakeholders
- Identify and drive opportunities for AI-assisted/agentic testing — requirements analysis, test-case generation, test-data generation, regression optimization, defect analysis

Skill Requirements

Other Requirements

📌 Senior Product Specialist (Chennai)
🏢 HCLTech
📍 Chennai