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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)
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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 maintenance activities:
User access management
Backup verification and system health checks
Troubleshoot issues with instrument interfaces and data capture.
Data Integrity & Compliance
Ensure ALCOA+ principles are followed for all data generated/stored in MODA.
Support audit trails review, electronic signatures, and security controls.
Collaborate with QA to ensure compliance with SOPs and regulatory requirements.
Stakeholder Collaboration
Act as bridge between IT and business users (QC Microbiology / QA).
Conduct user training and knowledge sharing sessions.
Work closely with global IT teams and vendors for issue resolution and enhancements.
Continuous Improvement
Identify and implement process improvements and automation opportunities.
Support system upgrades and new feature rollouts.
Maintain and update SOPs, work instructions, and technical documentation.
Travel Estimate
Frequent travelling for Project requirement and routine support.
Job Scope
Internal Interactions (within the organization)
Yes
External Interactions (outside the organization)
Yes
Job Requirements
Educational Qualification
BE, B.Tech IT or Computter, BCA, MCA, BSc./ Msc. IT
Specific Certification
Experience
5-7 years
Skill (Functional & Behavioural):
Strong problem-solving and analytical abilitie
Effective communication with cross-functional teams
Stakeholder management and vendor coordination
Documentation and audit readiness mindset
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).
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