TC
Trackwise Analyst
TechDigital Corporation
🇺🇸 United States
On-site
3 months ago
- CAPA
- GxP
- Visio
- Agile
- Scrum
- Jira
- Confluence
- MS Office
3 months ago
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
- 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
Trackwise Analyst · TechDigital Corporation