Munendra Singh

Designation: Sr. Manager – Information Technology (Site IT Head – 3 Manufacturing Plants)

Role: Infrastructure & Security

Responsibilities:

1. Manage end-to-end daily IT operations across all three manufacturing plants in Sikkim, ensuring high system availability and business continuity.

2. Lead IT-OT Cyber Security initiatives, including Vulnerability Management, EDR, ITD, DMG-OT, DLP, and SIEM monitoring to strengthen security posture.

3. Oversee Laboratory IT operations and ensure compliance with regulatory and internal quality standards.

4. Manage manufacturing OT user access and access governance to ensure secure and controlled operations.

5. Drive OT infrastructure projects, including the ongoing new FFS line upgradation and related technology deployments.

6. Manage backup and restoration of IT servers, critical systems, and endpoint machines to ensure disaster recovery readiness.

7. Implement new technologies and infrastructure upgrades such as Email Security, server modernization, switch upgrades, and integrated data center rack setup for two units.

8. Ensure audit readiness for RoW audits and internal audits by maintaining IT compliance and control frameworks.

9. Plan and support MES (Manufacturing Execution System) implementation in manufacturing operations to enable digital transformation.

10. Manage IT budget planning, cost optimization, and expense control for site operations.

11. Lead IT manpower planning, vendor coordination, and people management to ensure effective resource utilization and team performance.

• Responsible and Accountable for Jubilant Generics Ltd, Oral Solid Doses Manufacturing Plant Roorkee and Jubilant Pharmova Ltd, Nanjangud API Plant
• Digitalization: GxP/Non GxP Automations, Pharma 4.0 with using AI & ML
• Key role played in SAP S/4 HANA implementation
• Key role played in SAP Success Factor implementation in Jubilant pharmova
• Compliance: ensuring SOP compliance as define in Site SOPs & 21 CFR Part 11 guidelines, Support & contribute towards preparing & updating site SOPs
• Backup & Restore: Data backup on Server's/Cloud, IPC's (Lab System & Mfg System)
• Quality Control Lab Support: Data Backup & Data Security Control on Lab CS User Management, Audit Trail, QC Lab Software Installation and Troubleshooting with help of respective Vendor & 100% uptime of Labourites Computers
• Mfg System Support: Data Backup & Restoration, Time Synchronization, Data Security Control on systems, User Management as privileges as per Approved Privileges Matrix, Active user list, Audit trail review, & Vendor coordination
• QMS Contribution in QMS activities such as CCRs, incidents, deviations and CAPAs related to IT systems in a timely manner
• Audit Readiness & Support: Provide the Support During the Audit internal External Audit Maintain IT regulations & compliance all the time and regulatory audit support at sites
• IT Support: ensuring noise less IT support at Jubilant Generics Ltd, Oral Solid Doses Manufacturing Plant Roorkee and Nanjangud API Plant
• IT Infrastructure Management: - infra Suppports on IaaS, PaaS, SaaS, Servers and Network Management, End user Infra Support
• Backup-restoration, Archival-Retrieval of electronic data & security controls
• CSV: Computer System Validation of Application as V-Model, GAMP-5 strategy
• Monitoring, Execution & timely reporting for all the ongoing activities at sites
• Asset Management: Incident, Change, Maintain Asset Inventory record, Support of Asset Life cycle
• Change Managements: IT related Changes implementation after Approval of change advisory board (CAB)
• Data Centre: Manage & Monitor the Data Centre and ensure the uptime & contribute the changes as per requirement
• Budgeting: Yearly IT Budgeting, Procurement & Payment process at sites. financial aspects of project by coordinating budget and tracking expenses.
• Team Management: People Management and mentoring the team 8+ On role Resources and 20+ off role resources
• Held daily meetings with site staff to communicate priorities and project updates.

• Responsible for Sikkim & Guwahati Plants for IT Operations & GxP SOP Compliance & IT Application Installation & Configurations & Computer System Validation
• Site-IT Operations: SOP Compliance, Backup & Restore, User access Managements of Quality Control Lab & Mfg System and Its Support
• Data Centre Management, Performace Montoring
• Asset Management, Change Managements, Incident ManagementTeam Management, Budgeting
• Project Management: Projects and CSV Support for New Lab Computer Systems Application & Mfg System as per GAMP 5 strategy
• QMS activities: Responsible for Change control, incidents, deviations and CAPAs related to IT systems to support on preparing & updating site SOPs related to IT
• Team Size: Handling 40+ resource ( On role+Off Role)

• IT Infrastructure Management: - Servers and Network Management, End user Infra Support, Inventory management for IT Hardware and Software's
• Backup-restoration, Archival-Retrieval of electronic data & security controls
• SOP Compliance at Lupin OSD & Injectable Nagpur (US-FDA approved Plant)
• Project infra Planning & Support for LIMS (Labware) & EBPR (Pas-x)
• Successfully implemented the EBPR (Electronic Batch Processing Records) Pas-x in Injectable
• CSV Support for Application Validation Process.

• Infrastructure and Operation Management of 3 Lupin Plants (Mandideep, Indore & Nagpur)
• Maintain the FMS support with SLA
• Team Size 30+.

• Field operations & Team Management (20 Engineer) & Technical Support providing for AMC business across Chhattisgarh State.