Description

You will gather, analyze, and document business requirements, translating them into functional specifications, user stories, and acceptance criteria for pharmaceutical solutions.

This role is on-site.

Responsibilities

• Facilitate workshops and process-mapping activities to elicit requirements from stakeholders.
• Translate business needs into BRDs, FRDs, RTMs, and user stories using MS Visio.
• Support Agile teams through backlog refinement, sprint planning, and UAT coordination.
• Perform gap analysis, recommend process improvements, and manage validation activities in GxP-regulated environments.
• Coordinate SIT, UAT, and defect triage while ensuring compliance with pharmaceutical regulations.

Required Skills

• 10+ years of experience as a Business Analyst in the Pharma domain.
• Strong understanding of pharmaceutical business processes, Supply Chain, and Manufacturing.
• Experience in regulated environments (GxP), including 21 CFR Part 11, GAMP 5, and CSV.
• Proficiency in requirements gathering, business process mapping, and gap analysis.
• Expertise in UAT planning, execution, and defect triage.
• Hands-on experience with JIRA, Confluence, and MS Visio.
• Knowledge of Change Control, CAPA, Deviations, and Good Documentation Practices (GDP).
• Bachelor's degree in a relevant field.

Preferred Skills

• Experience with HP ALM / AQM.
• Experience handling AI projects.
• Proficiency in Microsoft Office Suite.

Key Skills

Education

Bachelor's degree