Role Description :
Seeking a skilled Functional cum Automation Tester with expertise in Veeva Vault Clinical Suite, including eTMF, CTMS, and Study Startup. The candidate should be capable of driving both manual and automated validation of Veeva Vault applications in GxP-regulated environments. Prior experience in clinical trial processes, Veeva Vault API testing, and automation frameworks is essential.
Key responsibilities :
- Design and execute functional test cases for Veeva Vault Clinical modules (eTMF, CTMS, SSU)
- Automate test scripts using tools compatible with Veeva Vault (e.g., Selenium, REST-assured for API, Postman)
- Validate end-to-end clinical workflows including document lifecycle, site management, and milestone tracking
- Perform data validations using Vault Loader, Vault APIs, and reporting features
- Ensure alignment with CSV standards, 21 CFR Part 11, and GxP requirements
- Maintain reusable automated regression suites and execute them in CI / CD pipelines
- Contribute to IQ / OQ / PQ phases, test traceability, and audit readiness
Technical skills requirements
4+ years of QA experience with 2+ years in Veeva Vault Clinical (eTMF, CTMS, SSU)Strong understanding of clinical trial workflows and regulatory documentationExperience with Veeva APIs, automation using Selenium or compatible frameworksFamiliarity with Vault Loader, Vault roles and permissions, and lifecycle configurationsProficient in test management and defect tracking tools (e.g., ALM, JIRA, TestRail)Experience in automated testing of GxP systemsExposure to validation documentation like URS, FRS, IQ / OQ / PQUnderstanding of Agile methodology and DevOps pipeline integrationNice-to-have skills :
Good to have basic knowledge of Azure Bachelor's Degree in Computer Science or related science field or equivalent.ref : hirist.tech)