Manager IT - Trackwise

Hi,

We are having an opening for Manager IT- Trackwise at our Baroda location

Job Summary

To lead the end-to-end implementation of the Quality applications (Preferably Trackwise) across the organization, ensuring alignment with regulatory requirements (GxP, 21 CFR Part 11), business needs, and global quality standards. Responsible for configurations and implementation and support quality systems to ensure Computer Systems, projects, processes and services meet their business and regulatory requirements. Follow the procedures defined in the Global SOPs during activities required for configuration and implementation of IT systems.

Areas Of Responsibility

• Oversee configuration, customization, and integration of TrackWise modules.
• Ensure validation documentation (IQ/OQ/PQ) is complete and compliant with GAMP 5 and Regulatory guidelines.
• Act as the lead between business units and project team.
• Conduct workshops, training sessions, and UAT coordination with end users.
• Ensure system design and implementation meet global regulatory standards.
• Maintain SOPs, traceability matrices, and change control documentation.
• Monitor system performance and user feedback to drive enhancements.
• Stay updated on system upgrades and industry best practices.
• Configuration creation based on the business requirements.
• Evaluation of business requirements for creation of best fit solution.
• Testing of configuration before releasing for validation.
• Provide technical training to the team members to get understand the configurations.
• Provide trainings to site coordinators for workflows implementations.
• Ensure configuration correctness during and post implementation.
• Investigation of incidents for technical resolution.
• Support QMS procedure for the applications
• Provide support to the end users as and when required for application functionalities and ensure system availability.
• Support the closure of the application related actions as required
• Creation of Validation documentation for configurations and system qualification.
• Provide support for the audit for computerized systems as and when required.
• Raising L3 support calls with vendor and ensure implementation of the resolution.
• Proficient in designing Reports using Crystal Report
• Proficient in writing Web Services using JAVA

Educational Qualification

Specific Certification

• Hands-on experience with TrackWise Digital or TrackWise Enterprise.
• Familiarity with LIMS, Documentum D2, or other QMS platforms.
• Excellent communication, leadership, and problem-solving skills.
• Ability to work in a global, matrixed environment.

Experience

Skills

• Strong understanding of GxP, 21 CFR Part 11, and CSV principles.
• Experience in managing cross-functional teams and vendor coordination