Job Description

Job Summary

At Sun Pharma, we commit to helping you Create your own sunshine— by fostering an workplace 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.

Role Summary

The IT Subject Matter Expert (SME) for Lonza MODA will be responsible for the implementation, configuration, validation, and ongoing support of the MODA Environmental Monitoring (EM) system within a regulated pharmaceutical environment. The role ensures system reliability, compliance (GxP/21 CFR Part 11), data integrity, and seamless integration with lab and manufacturing systems.

Areas Of Responsibility
- Implementation & Project Support
- Lead/support end-to-end deployment of Lonza MODA:
- Configure workflows,



sampling plans, alert/action limits, and test methods in MODA.
- Coordinate with Lonza vendor team, QA, QC Microbiology, and Manufacturing stakeholders.
- Support system integration with:
- Environmental monitoring instruments (e.g., particle counters, air samplers)
- LIMS, MES, or other quality systems
- Participate in installation, upgrades, patches, and system enhancements.
- Computer System Validation (CSV)
- Ensure adherence to GxP, 21 CFR Part 11, Annex 11, and data integrity requirements.
- Support/execute validation activities:
- Review and maintain validation documentation.
- Support audit readiness and regulatory inspections (FDA, EMA, MHRA, etc.).
- Routine Operations & Support
- Provide application support for MODA system issues.
- Manage incident, problem, and change requests (ITIL framework preferred).
- Monitor system performance, availability, and data accuracy.
- Perform routine m

📌 Manager 2 IT-Lonza Moda (Vadodara)
🏢 SUN PHARMA
📍 Vadodara