Description

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.Must-Have SkillsPharma DomainStrong understanding of pharmaceutical business processes.Experience working in regulated environments (GxP).Knowledge of:21 CFR Part 11GAMP 5Good Documentation Practices (GDP)Change Control, CAPA, DeviationsValidation Lifecycle (CSV)Business AnalysisRequirements Gathering & AnalysisBusiness Process MappingGap AnalysisUser Story CreationStakeholder ManagementDocumentation (BRD, FRD, RTM)UAT Planning and ExecutionToolsJIRAConfluenceMS VisioHP ALM / AQM (Good to Have)Microsoft Office Suite & Experience handling AI project (Good to have)

Key Skills

Education

Bachelor's degree