QMS Tester/ BA
Amgen
- Location
- India - Hyderabad
- Work model
- On-Site
- Level
- Senior
- H-1B history
- 137 approvals (FY2023)
- Posted
- 16h ago
Skills
About this role
Career Category Quality Job Description Role Overview We are looking for an experienced L3 Tester with 3–5 years of experience in Quality Management Systems , preferably with hands-on exposure to Veeva Vault QMS , to support functional testing, regression testing, defect validation, integration testing, release testing, and production support activities in a regulated life sciences environment. This is a hands-on testing role focused on validating QMS business processes, system configurations, integrations, reports, workflows, and controlled releases . The ideal candidate should be able to understand business requirements, prepare and execute test cases, document evidence, identify defects, perform retesting, and collaborate with functional, configuration, integration, and validation teams. The role requires strong understanding of QMS processes, testing fundamentals, defect lifecycle management, documentation discipline, and the ability to work effectively within Agile and GxP-compliant delivery models.
Key Responsibilities
QMS Functional Testing & Release Validation Analyze business requirements, user stories, acceptance criteria, and configuration design documents to prepare effective test scenarios and test cases for QMS processes. Execute functional, regression, integration, smoke, sanity, and user acceptance testing for Veeva Vault QMS or equivalent Quality Management Systems. Validate QMS workflows and business processes including deviations, CAPA, change control, audits, complaints, quality events, effectiveness checks, and related quality records. Perform end-to-end testing across configured objects, fields, layouts, lifecycles, roles, permissions, notifications, reports, and dashboards. Support integration testing by validating source-to-target data flows, interface outputs, error scenarios, and downstream reporting impacts. Log defects with clear reproduction steps, expected results, actual results, screenshots, evidence, severity, and business impact. Coordinate with configuration, development, integration, validation, and business teams for defect triage, retesting, closure, and release readiness. Agile Delivery & Collaboration Work closely with Business Analysts, Product Owners, Configuration Leads, Developers, Integration Teams, Validation Teams, and Business SMEs to understand testing scope and quality expectations. Participate in Agile ceremonies including sprint planning, backlog refinement, test planning, daily stand-ups, defect triage, and release readiness discussions. Support root cause analysis by providing clear test evidence, defect history, and scenario-level observations. Collaborate effectively with global teams across multiple time zones while maintaining strong documentation and communication discipline.
Required Qualifications
Required Experience Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Pharmacy, or a related field. 3–5 years of hands-on testing experience in enterprise applications, preferably within Quality Management Systems or regulated life sciences platforms. Experience testing QMS processes such as deviations, CAPA, change control, audits, complaints, investigations, and quality events. Working knowledge of Veeva Vault QMS, TrackWise, ETQ, MasterControl, or equivalent QMS applications is preferred. Experience preparing test scenarios, test cases, test execution evidence, defect reports, traceability matrices, and test summary reports. Experience with functional testing, regression testing, integration testing, UAT support, and release validation. Exposure to GxP, CSV, change control, validation documentation, and audit-ready testing practices is preferred. Required Technical Skills Strong hands-on testing experience with: QMS functional testing and business process validation Test case design, test execution, defect logging, retesting, and regression testing Veeva Vault QMS or comparable enterprise QMS platforms Workflow, lifecycle,