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.,

Job Summary

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 persons 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 server's 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

1. 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.

1. 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.

1. 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.

1. Stakeholder Collaboration

- Collaborate with Production, QA, QC, Regulatory Affairs, and Engineering teams to align IT with

business goals. Bachelors 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.
- Solid 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.

Preferred Certifications:
- ITIL
- GAMP 5, 21 CFR Part 11, Data Integrity training

PLEASE EMAIL UPDATED RESUMES TO [email protected]

📌 It Manager(Infra, Networking & GxP System)Pharma mfg co only,Mumbai
🏢 3 Point HRM
📍 Mumbai