TrackWise (QMS) Architect / Senior Developer – Remote | Contract

Role: TrackWise (QMS) Architect / Senior Developer
Experience: 8+ Years enterprise QMS | 5+ years hands-on TrackWise
Work Location: Remote

Job Description

We are looking for an experienced TrackWise (QMS) Architect / Senior Developer to lead the technical upgrade of TrackWise Classic from version 10.2 to 10.14 within a validated GxP environment.

This is a hands-on technical architect position requiring strong experience in TrackWise configuration, customization, version upgrades, integrations, SQL, validation, and regulated life sciences environments.

Key Responsibilities

- Own the end-to-end technical design and execution of the TrackWise Classic 10.2 to 10.14 upgrade
- Assess existing TrackWise configurations, workflows, custom code, reports, integrations, and database components
- Prepare detailed upgrade impact assessments and remediation plans
- Lead upgrades across DEV, QA, VAL, and PROD environments
- Handle database schema migration and environment builds
- Remediate deprecated or incompatible customizations, including scripts, custom DLLs, stored procedures, InfoCards, form logic, and workflows
- Reconfigure and test integrations using web services, ODBC/DB links, ERP, LIMS, MES, and eDMS
- Rebuild and validate reports and analytics impacted by the upgrade
- Support IQ/OQ/PQ, traceability matrices, regression testing, CSV, and QA validation activities
- Define and execute cutover, rollback, go-live, and hypercare plans




- Mentor TrackWise developers and administrators and provide complete technical handover documentation

Required Skills & Experience

- 8+ years of enterprise QMS experience
- 5+ years of hands-on TrackWise Classic (9.x/10.x) experience
- Strong experience as a TrackWise Architect or Senior Developer
- Mandatory end-to-end TrackWise version upgrade experience
- Strong TrackWise configuration experience covering:
- Workflows
- Project and field configuration
- Security model
- Coordinator
- Windows Server / IIS architecture
- Robust Oracle and/or SQL Server experience, including stored procedures, query optimization, and performance tuning
- Hands-on development experience with .NET/C#, VBScript, and JavaScript in TrackWise customizations/extensions
- Strong understanding of 21 CFR Part 11, GAMP 5, Computer System Validation (CSV), GxP, and ALCOA+
- Strong QMS process knowledge across CAPA, Deviations, Complaints, Audits, Change Control, and Supplier Quality

Preferred Qualifications

- Experience in pharmaceutical, life sciences, medical devices, or regulated manufacturing
- Experience with TrackWise Analytics, Crystal Reports, or SAP BusinessObjects
- Exposure to TrackWise Digital
- Experience with validated cloud/on-premises migrations and infrastructure modernization

What Success Looks Like

Within the initial phase of the engagement, the successful candidate should be able to complete the upgrade impact assessment, define the remediation backlog, and establish a stable and validated TrackWise 10.14 non-production environment.

Pay: ₹130,000.00 - ₹140,000.00 per month

Work Location: Remote

📌 TrackWise Architect/senior Developer (India)
🏢 Kasmoprav
📍 India