Business Analyst

Amgen; India; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Amgen seeks an experienced L3 Tester with 3-5 years in Quality Management Systems to support functional, regression, and integration testing within a regulated life sciences environment. You will validate QMS processes, configurations, reports, workflows, and controlled releases, collaborating with cross-functional teams in an Agile, GxP setting.

The role emphasizes testing of deviations, CAPA, change control, audits, and quality events, with hands-on validation across QMS platforms like Veeva

Qualifications

• Bachelor's degree in CS/IS/Engineering/Life Sciences/Pharmacy or related field.
• 3-5 years of hands-on testing in enterprise applications, preferably QMS/regulatory.
• Experience with QMS processes like deviations, CAPA, change control, audits, complaints, and quality events.

Responsibilities

• Analyze requirements, stories, and configuration docs to create test scenarios and cases for QMS processes.
• Execute functional, regression, integration, smoke, sanity, and UAT testing for QMS systems.
• Validate QMS workflows, deviations, CAPA, change control, audits and quality records.

Skills

QMS testing

Veeva Vault QMS

Test design

Jira

SQL basics

UAT support

Education

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Pharmacy, or related field

Tools

Veeva Vault QMS

TrackWise

ETQ

MasterControl

Jira

ALM

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, role, permission, notification, report, and dashboard validation
• Integration testing, data validation, interface checks, and error scenario testing
• ALM, Jira, Veeva VM or equivalent test management tools
• Test evidence documentation, traceability, and audit-ready execution practices
• Good understanding of QMS processes including deviations, CAPA, change control, audits, complaints, and quality events.
• Ability to understand configuration changes and assess testing impact across related QMS workflows and downstream processes.
• Working knowledge of SQL or basic data validation techniques is preferred.
• Understanding of GxP validation, controlled documentation, traceability, and release testing expectations.

Preferred Skills

• Experience testing Veeva Vault Quality/QMS workflows, records, reports, dashboards, and controlled configuration changes.
• Experience in Life Sciences, Pharmaceutical, Biotechnology, or GxP-regulated environments.
• Exposure to CSV validation deliverables, requirement traceability