UAT Tester

1 week ago

Bengaluru Chennai Hyderabad, India HCLTech Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Job Location - Chennai & Hyderabad

Keywords Safety Systems, Regulatory submissions, labeling, publishing, RIMS (Veeva, etc.)

Roles and Responsibilities

Must Have

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Regulatory Sciences, or Computer Science.
  • 4–8 years of experience in IT testing/validation, with 2–4 years in Regulatory Affairs systems
  • Work with Regulatory Affairs, Publishing, Labeling, and IT teams to understand business processes and URS (User Requirement Specifications).
  • Hands-on experience with Regulatory applications (e.g., Veeva Vault RIM, Lorenz docuBridge, Liquent InSight, Extedo eCTDmanager, or similar).
  • Develop UAT strategy, test plans, test cases, and traceability matrices aligned with RA workflows.
  • Execute UAT test scripts, document results, log defects, and track resolution with IT/vendors.
  • Validate workflows related to submission planning, document authoring, publishing, eCTD compilation, electronic submissions, and labeling/artwork review.
  • Perform regression testing for system upgrades, patches, and integrations with DMS, QMS, Safety, and Clinical systems.
  • Verify compliance with 21 CFR Part 11, GAMP 5, ICH, and regional regulatory submission guidelines.
  • Validate metadata management, version control, and controlled vocabularies for submissions.
  • Ensure readiness for global submissions (NDA, MAA, IND, CTA, ANDA, variations, renewals).
  • Support end-user readiness, training, and sign-off for UAT completion.
  • Document deviations, manage defect triage, and ensure timely closure.
  • Provide UAT summary reports, support release readiness decisions, and maintain audit trail.
  • Contribute to audit/inspection readiness by maintaining UAT documentation.
  • Identify process improvement opportunities and support test automation initiatives.

Good to Have (secondary skills)

  • Strong knowledge of Regulatory submissions, eCTD structure, publishing workflows, labeling, and lifecycle management.
  • Experience with UAT methodology, SDLC, and CSV (Computer System Validation).
  • Familiarity with global regulatory guidelines (FDA, EMA, MHRA, PMDA, Health Canada).
  • Proficiency with defect tracking tools (JIRA, HP ALM, Veeva QMS).
  • Excellent communication, documentation, and cross-functional collaboration skills.
  • Strong analytical and problem-solving mindset.

Communication

  • Immaculate communication and handles multiple clients/ projects
  • Works in Consulting capacity Regulatory Affairs Applications

Best Regards,

Sanjay Kumar

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