Employment type – Contract
Job Title – Trackwise Analyst
Job Location – Indianapolis, Indiana
Duration – 6 months
Experience level – L3
Mandatory Skills – Trackwise Funcional , Business Analysis
Job 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
Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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