Job Summary

• 5-7 years of experience as a Business Analyst in Pharma or Life Sciences environments.
• Strong understanding of SDLC phases including requirements, design, development, testing, deployment, and maintenance in regulated environments.
• Collaborate with Quality, Regulatory, and business stakeholders to gather, analyze, and document business and system requirements aligned with Pharma GxP standards.
• Translate business requirements into BRDs, FRDs, URS/FRS documents, user stories, and acceptance criteria.
• Develop and maintain traceability matrices, process flows, and SOP-aligned documentation.
• Strong understanding of GxP, FDA regulations, CSV, and validation processes.
• Ensure all system and reporting requirements align with Pharma GxP standards (GMP, GCP, GLP) and 21 CFR Part 11 requirements.
• Experience working with cross-functional teams in regulated environments.
• Excellent communication, stakeholder management, and analytical skills.
• Support Computer System Validation (CSV) activities, including authoring or reviewing validation plans, risk assessments, and test scripts
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.

Key Responsibilities

• 5-7 years of experience as a Business Analyst in Pharma or Life Sciences environments.
• Strong understanding of SDLC phases including requirements, design, development, testing, deployment, and maintenance in regulated environments.
• Collaborate with Quality, Regulatory, and business stakeholders to gather, analyze, and document business and system requirements aligned with Pharma GxP standards.
• Translate business requirements into BRDs, FRDs, URS/FRS documents, user stories, and acceptance criteria.
• Develop and maintain traceability matrices, process flows, and SOP-aligned documentation.
• Strong understanding of GxP, FDA regulations, CSV, and validation processes.
• Ensure all system and reporting requirements align with Pharma GxP standards (GMP, GCP, GLP) and 21 CFR Part 11 requirements.
• Experience working with cross-functional teams in regulated environments.
• Excellent communication, stakeholder management, and analytical skills.
• Support Computer System Validation (CSV) activities, including authoring or reviewing validation plans, risk assessments, and test scripts
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.

Skill Requirements

1. Proficient in data analysis techniques and tools such as sql, python, or r.
2. Strong business analysis skills including requirements gathering, process mapping, and solution design.
3. Experience working in agile environments using methodologies like scrum or kanban.
4. Excellent communication and stakeholder management skills.
5. Ability to work collaboratively in cross functional teams to achieve project goals.
6. Analytical mindset with a detail oriented and problem-solving approach.
7. Project management skills to effectively prioritize tasks and meet deadlines.

Other Requirements

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