KH
Business Analyst
Katalyst Healthcares & Life Sciences
🇵🇷 Puerto Rico
On-site
Mid level
2 months ago
- GxP
- Agile
- Visio
- triage
- CAPA
- Jira
- Confluence
- AI
2 months ago
- 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.
- 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.
- 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.
Business Analyst · Katalyst Healthcares & Life Sciences