Description

You will bridge business and technology teams to deliver digital transformation, validation, data, and quality initiatives within regulated pharmaceutical environments.

This role is on-site.

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.
• Support Agile delivery teams in backlog refinement, sprint planning, and UAT activities.
• Perform gap analysis, recommend process improvements, and ensure compliance with pharmaceutical regulations.

Required Skills

• 5–10 years of experience as a Business Analyst in the Pharma Domain.
• Strong knowledge of GxP regulations, 21 CFR Part 11, GAMP 5, and Good Documentation Practices (GDP).
• Experience with validation lifecycle (CSV), Change Control, CAPA, and Deviations.
• Proficiency in requirements gathering, business process mapping, and gap analysis.
• Hands-on experience with JIRA, Confluence, and MS Visio for documentation and tracking.
• Ability to create and maintain BRDs, FRDs, RTMs, and user stories.
• Experience coordinating SIT, UAT, and defect triage activities.

Preferred Skills

• Familiarity with HP ALM / AQM.
• Experience handling AI projects.

Key Skills

Education

Bachelor's degree