Req ID – 10903564

Job Title: Engineer

Work Location: ~HYDERABAD~PUNE~NOIDA~

Skills Required: EIS : Trackwise

Experience: 8-10

Roles & Responsibilities

Position Overview

We are looking for an experienced TrackWise Digital Specialist to support and enhance Quality Management System (QMS) processes using Sparta TrackWise Digital. The ideal candidate will have hands-on experience in configuration, administration, and implementation of TrackWise Digital in a regulated setting, preferably within pharma, biotech, or life sciences industries.

Key Responsibilities

● Configure, customize, and support TrackWise Digital (Sparta Systems) platform

● Manage QMS processes including Deviations, CAPA, Change Control, Complaints, Audits, and Document Management

● Collaborate with business stakeholders to gather requirements and implement solutions within TrackWise Digital

● Perform system administration activities including user management, workflows, and security roles

● Lead and support Computer System Validation (CSV) activities (IQ, OQ, PQ)

● Ensure compliance with GxP standards, 21 CFR Part 11, and data integrity requirements

● Troubleshoot system issues and provide timely resolutions

● Support system upgrades, releases, and enhancements

● Integrate TrackWise Digital with other enterprise systems (ERP, LIMS, etc.)

● Prepare and maintain SOPs, validation documentation, and user guides

● Conduct end-user training and provide ongoing support

Preferred Qualifications

● Experience with TrackWise 8 to TrackWise Digital migration

● Knowledge of cloud-based platforms and SaaS solutions

● Exposure to system integrations and APIs

● Basic understanding of databases or scripting





● Certification in TrackWise Digital (if available)

● Educational background in Life Sciences, Pharmacy, or Engineering

Role Descriptions: Configure| customize| and support TrackWise Digital (Sparta Systems) platformManage QMS processes including Deviations| CAPA| Change Control| Complaints| Audits| and Document ManagementCollaborate with business stakeholders to gather requirements and implement solutions within TrackWise DigitalPerform system administration activities including user management| workflows| and security rolesLead and support Computer System Validation (CSV) activities (IQ| OQ| PQ)Ensure compliance with GxP standards| 21 CFR Part 11| and data integrity requirementsTroubleshoot system issues and provide timely resolutionsSupport system upgrades| releases| and enhancementsIntegrate TrackWise Digital with other enterprise systems (ERP| LIMS| etc.)Prepare and maintain SOPs| validation documentation| and user guidesConduct end-user training and provide ongoing supportExperience with TrackWise 8 to TrackWise Digital migrationKnowledge of cloud-based platforms and SaaS solutionsExposure to system integrations and APIsBasic understanding of databases or scriptingCertification in TrackWise Digital (if available)Educational background in Life Sciences| Pharmacy| or Engineering

Essential Skills: We are looking for an experienced TrackWise Digital Specialist to support and enhance Quality Management System (QMS) processes using Sparta TrackWise Digital. The ideal candidate will have hands-on experience in configuration| administration| and implementation of TrackWise Digital in a regulated environment| preferably within pharma| biotech| or life sciences industries.

Desirable Skills

Keyword

Skills: EIS : Trackwise

Experience Required: 8-10

📌 EIS : Trackwise (Hyderabad)
🏢 TCS_India
📍 Hyderabad