Business Analyst - Gxp Expertise

Role description Job Title: Business Analyst – (QA & Documentation Focus) Experience: 6–10+ years Role Overview We are seeking a seasoned Business Analyst with strong Gxp expertise to support high-quality document deliverables through URS/FRS documentation review, IQ, OQ, UAT test script review and execution in a regulated environment. Core Skills · Strong experience as a Business Analyst in Life Sciences/Pharma domain Knowledge of QA tools (ALM, JIRA, etc.) 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. · Ensure the validations on all the SDLC documents are accurate · Collaborate with stakeholders (business, QA, IT) to refine requirements. · Act as a liaison between business stakeholders, Testing teams, and technical teams. · 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.