IT Manager

Exeltis India; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Exeltis India is seeking an experienced IT Manager to lead IT infrastructure, networking, and production/QC instrumentation across the site in Mumbai. The role requires strong compliance knowledge with USFDA, GxP, CFR Part 11, and data integrity, with oversight of audits and inspections.

You will manage IT operations to support manufacturing, QA, QC, and regulatory affairs, drive security, backup, DR plans, and IT validation, while collaborating with cross-functional teams to align IT with

Qualifications

• Bachelor's degree in IT/CS or related field.
• 15+ years IT management experience in a pharmaceutical manufacturing site.
• Expertise in IT infrastructure, networking, and cybersecurity.
• Experience with GxP, 21 CFR Part 11, and data integrity requirements.
• Familiarity with SCADA, LIMS, Empower, and other lab automation systems.
• Strong understanding of pharmaceutical regulatory requirements (USFDA, EU GMP, MHRA, WHO).
• Hands-on IT validation and audit management experience.
• Excellent leadership and communication skills.

Responsibilities

• Lead IT infrastructure, networking, and production/QC instrumentation IT.
• Ensure compliance with USFDA, GxP, CFR Part 11 and 21 CFR data integrity.
• Manage audits and regulatory inspections related to IT.
• Coordinate with Production, QA, QC, Regulatory Affairs, and Engineering.
• Oversee security, backup, DR, and business continuity.

Skills

IT management

Leadership

Regulatory IT compliance

Audits

Vendor management

Cloud management

Education

Bachelor's degree in Information Technology/Computer Science

Tools

SCADA

LIMS

Empower

Fortinet Firewall

Veeam Backup

Job description

We are seeking an experienced IT Manager to lead the IT infrastructure, networking, and production/QC instrumentation. The candidate should be able to manage the overall business requirements and should v. compliance knowledge with USFDA, GxP, CFR Part 11, and other regulatory IT requirements, while managing IT operations to support manufacturing and quality control. Should have faced various audits like USFDA, European Audits, Other audits etc.,

Key Responsibilities:

1. IT Infrastructure Networking Management

• Oversee IT infrastructure, including servers, storage, networking, and data centers.
• Manage enterprise LAN/WAN, VPN, and cybersecurity solutions.
• Ensure high availability and performance of IT systems supporting production and QC.
• Work with external vendors and service providers for IT support and upgrades.
• Configuring, Managing and Troubleshooting: Servers, Laptops, Desktops, Local and Network Printers, Network Devices
• Storage Devices, Backup and Recovery
• Setup, Planning, and designing of policies on Fortinet Firewall to safeguard the data.
• Based on the Authorized person s approvals, provide required access to the IT resources for the specified time depending upon the requirement.
• Management of active directory service which includes user management and Role Base Access Control of the Organizational data hosted on Windows
• Managing File and Storage Server access.
• Planning and Implementing AD Group policies, login/logout Scripts, and User Roaming profiles.
• Backup management of Active Directory for quick recovery and high availability.
• Windows Client and Server patch management tools
• Review and Management of Antivirus software to ensure Client machines and Servers are protected.
• Monitoring servers Health and Resource management to ensure 100% uptime.
• Hardware and Software inventory management.
• Handling issues about IT based on the requests and calls on a priority basis.
• Veeam Backup Management
• AWS Cloud Server Management

2. Production QC Instrumentation Support

• Manage and support GxP-compliant IT systems used in manufacturing and quality control (QC).
• Ensure seamless integration of production instruments (e.g., PLCs, SCADA) with enterprise IT systems.
• Oversee QC instrumentation (e.g., HPLC, GC, UV, FTIR, and other lab equipment) from an IT compliance perspective.
• Ensure 21 CFR Part 11 and data integrity compliance for QC systems.

3. Regulatory Compliance IT Validation

• Knowledge in implementation of IT policies and procedures to comply with USFDA, MHRA, EU GMP, WHO, and other regulatory bodies. IT validation and qualification (IQ, OQ, PQ) for production and QC systems.
• Ensure audit readiness and participate in regulatory inspections related to IT systems.
• Maintain IT SOPs, risk assessments, and CAPA documentation.

4. Security Business Continuity

• Knowledge in implementation of if IT security frameworks (e.g., ISO 27001, NIST).
• Ensure backup, disaster recovery, and business continuity plans are in place.
• Monitor and respond to IT security incidents and ensure data protection.

5. Stakeholder Collaboration

• Collaborate with Production, QA, QC, Regulatory Affairs, and Engineering teams to align IT with business goals.

Required Qualifications Experience:

• Bachelor s degree in Information Technology/Computer Science, or a related field.
• 15+ years of experience in IT management within a pharmaceutical manufacturing site
• Expertise in IT infrastructure, networking, and cybersecurity.
• Experience with GxP-compliant systems, 21 CFR Part 11, and data integrity requirements.
• Familiarity with SCADA, LIMS, Empower, and other lab automation systems.
• Strong understanding of pharmaceutical regulatory requirements (USFDA, EU GMP, MHRA, WHO, etc.).
• Hands-on experience in IT validation, CSV (Computer System Validation), and audit management.
• Excellent leadership, communication, and problem-solving skills.

Language Proficiency:

• Good communication skills
• Familiar with Hindi and English

Preferred Certifications:

• ITIL
• GAMP 5, 21 CFR Part 11, Data Integrity training.