Role : 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 environment. 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.