Business Analyst - Gxp Expertise

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.