TrackWise Digital Specialist

Zodiac HR Consultants; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Zodiac HR Consultants in Bengaluru seeks an experienced TrackWise Digital Specialist to lead hands-on TrackWise Digital and TrackWise QMS initiatives in regulated pharma environments. You will configure, customize and support TrackWise applications, manage Deviations, CAPA, Change Control, Complaints and Audits, and contribute to CSV, validation and compliance efforts.

The role includes ERP/LIMS integrations and API work, plus user management and security.

Qualifications

• Experience in TrackWise Digital/QMS within regulated life sciences environments.
• Experience with Deviations, CAPA, Change Control, Complaints and Audits.
• Familiarity with CSV and 21 CFR Part 11 compliance.

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

Skills

Deviations & CAPA

Change Control, Complaints & Audits

User Management & Workflow Configurat​

Computer System Validation (CSV)

GxP / 21 CFR Part 11

Tools

TrackWise Digital

TrackWise QMS

TrackWise Configuration & Administration

ERP / LIMS Integration

System Integration / APIs

Job description

We are looking for an experienced TrackWise Digital Specialist with strong 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