Job Description

Job Title:
IT- Manager(Trackwise)
Job Grade (refer to JE)
G10A
Function:
IT
Location:
Tandalja(Baroda)
Areas Of Responsibility
At Sun Pharma, we commit to helping you "Create your own sunshine"- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."
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 SOP's during activities required for configuration and implementation of IT systems.

• 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

Travel Estimate
Frequent travelling for Project rollout
Job Scope
Internal Interactions (within the organization)
Yes
External Interactions (outside the organization)
Yes
Geographical Scope
NA
Financial Accountability (cost/revenue with exclusive authority)
Partial
Job Requirements
Educational Qualification

• Bachelor's or Master's in Computer Science, IT or related field.

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

• 7+ years of experience in pharmaceutical quality systems, with 5+ years in TrackWise implementation.

Skill (Functional & Behavioural):

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

Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

Skills Required