We are looking for an experienced TrackWise Digital Specialist with robust hands-on experience in TrackWise Digital / TrackWise QMS and regulated Life Sciences environments.
Experience: 6-8 Years
Location: Bengaluru
Domain: Pharma / Life Sciences / Biotech / Regulated QMS
Key Skills:
TrackWise Digital
TrackWise QMS
Deviations & CAPA
Change Control, Complaints & Audits
TrackWise Configuration & Administration
User Management & Workflow Configuration
Computer System Validation (CSV)
GxP / 21 CFR Part 11
System Integration / APIs
ERP / LIMS Integration
Key Responsibilities:
- Configure, customize and support TrackWise Digital applications
- Manage QMS processes including Deviations, CAPA, Change Control, Complaints and Audits
- Support workflows, user administration and security roles
- Participate in CSV, validation and compliance activities
- Troubleshoot application issues and perform root-cause analysis
- Support upgrades, releases and enhancements
- Work on integrations with ERP, LIMS and other enterprise systems
- Prepare SOPs, validation documents and user guides
Good to Have: TrackWise 8 to TrackWise Digital migration, SaaS/Cloud exposure, API integrations, database/scripting knowledge and TrackWise certification