Manager 2 IT-Lonza Moda

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is seeking an IT Subject Matter Expert to implement and support the MODA Environmental Monitoring system in Vadodara, India. You will ensure compliance with regulatory standards and support system integration with quality systems.

The ideal candidate will have 5-7 years of experience, a relevant degree, and strong communication skills for cross-functional collaboration.

Qualifications

• 5-7 years of experience in IT or related fields.
• Strong analytical capabilities for troubleshooting.
• Experience with cross-functional team collaboration.

Responsibilities

• Oversee the implementation and support of the MODA system.
• Ensure compliance with regulatory standards.
• Monitor system performance and data integrity.

Skills

Problem-solving abilities

Effective communication

Stakeholder management

Documentation mindset

Education

BE, B.Tech in IT, BCA, MCA, BSc., Msc. IT

Job description

Job Summary

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.

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:
• 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 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.
• Identify and implement process improvements and automation opportunities.
• Support system upgrades and new feature rollouts.
• Maintain and update SOPs, work instructions, and technical documentation.

Frequent travelling for Project requirement and routine support.

Job Requirements

Educational Qualification

BE, B.Tech IT or Computter, BCA, MCA, BSc./ Msc. IT

Specific Certification

NA

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

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).