Business Analyst

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, test protocols, and audit support.
• Basic understanding of integrations, API testing concepts, data mapping, and interface validation.
• Familiarity with Agile delivery, release management, change control, and production support processes.

Preferred Certifications

• Veeva Vault certification or training preferred.
• GxP, CSV, or computer system validation training preferred.

Soft Skills

• Strong attention to detail and commitment to quality documentation.
• Analytical mindset with strong defect investigation and troubleshooting skills.
• Clear written and verbal communication skills for defect reporting, test status updates, and stakeholder coordination.
• Ability to work independently while collaborating effectively with cross-functional global teams.
• Organized, process-oriented, and comfortable working in Agile and regulated delivery environments.
• Ability to manage multiple testing priorities across sprint, release, and production support timelines.

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