Acceptance Testing, Agile Programming Methodologies, Analysis Skills, Atlassian JIRA, Biology, Biotech and Pharmaceutical, Bug Tracking/Defect Management, Business Analysis, Change Control, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Environmental Sciences, Functional Analysis, Functional Requirements Document (FRD), GxP, Maintain Compliance, Microsoft Office, Microsoft Visio, Problem Solving Skills, Quality Management, Regulatory Compliance, Requirements Management, Scrum Project Management and Software Development
Trackwise Functional, Business Analysis
Role Description:
Business Analyst with strong TrackWise functional expertise to support and enhance Quality Management System (QMS) processes in a regulated Life Sciences environment. The role involves requirement analysis, stakeholder coordination, and ensuring successful delivery of TrackWise-based solutions.
Key Responsibilities:
- Gather, analyze, and document business and functional requirements (BRD/FRD/User Stories)
- Act as a bridge between business stakeholders and technical teams
- Provide functional support for TrackWise modules (Deviation, CAPA, Change Control, Audit, Complaints)
- Conduct process mapping (As-Is / To-Be) and identify improvement opportunities
- Support UAT planning, execution, and defect management
- Ensure compliance with GxP and regulatory standards
- Collaborate with cross-functional teams for smooth delivery and issue resolution
Required Skills
- Strong hands-on experience with TrackWise (QMS platform)
- Solid understanding of Quality processes in Pharma / Life Sciences
- Experience in requirement gathering, documentation, and stakeholder management
- Knowledge of process mapping tools (Visio/BPMN)
- Familiarity with Agile/Scrum methodologies
Tools: JIRA, Confluence, MS Office Suite