TrackWise (QMS) Architect / Senior Developer

Engagement Type Contract / Full-time

Location Remote / Bangalore

Experience 8+ years enterprise QMS | 5+ years hands-on TrackWise

ROLE OVERVIEW

Own the technical design and execution of a TrackWise Classic upgrade from 10.2 to 10.14 within a validated GxP setting. This is a hands-on architect role covering configuration migration, custom code remediation, integration re-certification, and validation support through cutover and hypercare.

KEY RESPONSIBILITIES

- Assess the current 10.2 footprint — configuration, custom code, workflows, reports, and integrations — and produce a documented upgrade impact and remediation plan.
- Lead the technical upgrade across DEV, QA, VAL, and PROD environments, including database schema migration and environment builds.
- Remediate deprecated or broken customisations: scripts, custom DLLs, stored procedures, InfoCards, form logic, and workflow logic.
- Re-point and re-test integrations — web services, ODBC/DB links, and interfaces to ERP, LIMS, MES, and eDMS platforms as applicable.
- Rebuild or validate reporting and analytics affected by the version change.
- Author and support IQ-OQ-PQ, traceability matrices, and regression test artefacts; partner with CSV and QA on validation deliverables.
- Define cutover, rollback, and hypercare plans; provide post-go-live support.
- Mentor developers and administrators, and deliver complete technical handover documentation.





REQUIRED QUALIFICATIONS

- 8+ years in enterprise QMS delivery, including 5+ years hands-on TrackWise (Classic 9.x / 10.x) as an architect or senior developer.
- Demonstrated end-to-end TrackWise version upgrade experience — not administration alone.
- Strong SQL (Oracle and/or SQL Server): stored procedures, query optimisation, performance tuning.
- TrackWise configuration depth: workflows, project and field configuration, security model, Coordinator, and web/app server architecture (Windows Server, IIS).
- Custom code experience with .NET / C#, VBScript, and JavaScript as used in TrackWise extensions.
- Regulated delivery background: 21 CFR Part 11, GAMP 5, computer system validation, and data integrity (ALCOA+).
- Quality process fluency across CAPA, Deviations, Complaints, Audits, Change Control, and Supplier Quality.

PREFERRED QUALIFICATIONS

- Life sciences, medical device, or pharmaceutical manufacturing industry background.
- TrackWise Analytics, Crystal Reports, or SAP BusinessObjects experience.
- Exposure to TrackWise Digital to support future-state roadmap discussions.
- Experience with validated cloud or on-premise migrations and infrastructure modernisation alongside upgrades.

SUCCESS IN THE FIRST 90 DAYS Upgrade impact assessment signed off, remediation backlog fully scoped, and a validated non-production 10.14 environment stood up and stable.

📌 Trackwise Architect (India)
🏢 Compunnel
📍 India