Business Analyst

Job Summary: * We are seeking an experienced Business Analyst with Pharma Domain expertise to bridge business and technology teams in delivering digital transformation, validation, data, and quality initiatives within regulated pharmaceutical environments. * The ideal candidate should have strong knowledge of pharmaceutical business processes, GxP regulations, and requirements management, with experience working across Manufacturing, Quality, Laboratory, Supply Chain, Validation, and IT functions.

Roles \& Responsibilities: * Gather, analyze, and document business requirements from stakeholders. * Facilitate workshops, requirement elicitation sessions, and process mapping activities. * Translate business requirements into functional specifications, user stories, and acceptance criteria. * Collaborate with business SMEs, Quality, Manufacturing, Supply Chain, Validation, and IT teams. * Support Agile delivery teams in backlog refinement, sprint planning, and UAT activities. * Perform gap analysis and recommend process improvements. * Create and maintain business process flows (Visio), BRDs, FRDs, RTMs, and user stories. * Support validation activities in GxP-regulated environments. * Coordinate testing activities including SIT, UAT, and defect triage. * Ensure solutions comply with pharmaceutical regulations and quality standards. * Act as the liaison between business stakeholders and technical teams.

Experience: * 5 10 years of experience as a Business Analyst in the Pharmaceutical domain. * Strong understanding of pharmaceutical business processes. * Experience working in GxP-regulated environments. * Knowledge of 21 CFR Part 11, GAMP 5, Good Documentation Practices (GDP), Change Control, CAPA, Deviations, and Validation Lifecycle (CSV). * Experience in requirements gathering and analysis, business process mapping, gap analysis, user story creation, stakeholder management, BRD, FRD, RTM documentation, and UAT planning and execution. * Proficiency with JIRA, Confluence, MS Visio, Microsoft Office Suite, and Client ALM/AQM (Good to Have). * Experience handling AI projects is a plus.