Job Summary
Job Title: Senior Business Analyst – VeevaVault QMS (QA & Documentation Focus)
Experience: 6–10+ years
Role Overview
We are seeking a seasoned Senior Business Analyst with VeevaVault QMS expertise to support high-quality document deliverables through URS/FRS documentation review, IQ, OQ, UAT test script review and execution in a regulated environment.
Key Responsibilities
Key Responsibilities
• Ensure requirements align with business processes, regulatory standards (GxP), and validation standards and best practices.
• Review and validate User Requirement Specifications (URS) and Functional Specifications (FRS) for completeness, clarity, and compliance.
• Identify gaps, inconsistencies, or missing scenarios in documentation and provide actionable recommendations.
• Collaborate with stakeholders (business, QA, IT) to refine requirements.
• Act as a liaison between business stakeholders, Testing teams, and technical teams.
• Provide functional insights and recommendations based on Veeva capabilities.
• Review test scenarios, test cases, and test scripts for coverage, accuracy, and traceability to URS/FRS.
• Validate test data requirements and expected results.
• Ensure compliance with validation standards and documentation traceability matrix (RTM), testing workflows, and approvals in ALM tools (HP ALM).
• Support User Acceptance Testing (UAT) by guiding users, clarifying requirements, and resolving issues.
• Identify defects and gaps during dry runs and ensure timely resolution.
Skill Requirements
Core Skills
• Strong experience as a Business Analyst in Life Sciences/Pharma domain with Veeva Vault QMS experience
• Knowledge of QA tools (ALM, JIRA, etc.)