IT Executive

1. Job Purpose

• To manage and maintain IT infrastructure and computerized systems in compliance with GMP,
• Data Integrity, and regulatory requirements (EDQM, USFDA, WHO), ensuring smooth plant
• operations and audit readiness.

2. Key Roles & Responsibilities:

• 2.1 IT Infrastructure Management
• Maintain and support all IT assets including desktops, laptops, servers, printers, and networking
• equipment
• Ensure proper functioning of LAN/WAN, internet, firewall, antivirus, and CCTV systems
• Perform installation, configuration, and troubleshooting of hardware and software
• 2.2 Regulatory Compliance & Data Integrity
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
• Maintain user access control, audit trails, and system security
• Support Computer System Validation (CSV) activities (IQ/OQ/PQ)
• Ensure all GxP systems remain validated and compliant
• 2.3 QC Instrument Software Support
• Provide support for software linked to instruments like HPLC, GC, Malvern, UV
• Ensure proper data recording, storage, and retrieval
• Coordinate with vendors for maintenance and troubleshooting
• 2.4 Data Backup & Security
• Perform and monitor regular data backups and restoration checks
• Maintain backup logs and ensure data protection
• Implement cybersecurity measures to prevent unauthorized access
• 2.5 Documentation & Audit Compliance
• Prepare and maintain IT SOPs, policies, and records
• Maintain logs: backup, access control, change control, and incidents
• Support internal and external audits (EDQM, USFDA, WHO-GMP, customer audits)
• Address audit observations and implement CAPA
• 2.6 User Support & Training
• Provide IT support to all departments (QA, QC, Production, Warehouse, Admin)
• Install and configure required systems and applications
• Train employees on IT systems and data integrity practices
• 2.7 Change Control & Incident Management
• Participate in change control for system upgrades and modifications
• Handle IT-related deviations, incidents, and CAPA
• 2.8 Vendor Management
• Coordinate with external vendors for IT services, AMC, and procurement
• Ensure timely service and system uptime
• 3. Educational Qualification:
• Bachelors Degree in IT / Computer Science / BCA / MCA / B.E. (IT/Computer)

3. Authority & Responsibility:

• Responsible for maintaining IT systems and ensuring compliance
• Authorized to control user access and system security
• Responsible for IT documentation and audit readiness

4. Working Conditions:

Based at manufacturing plant

May require support during audits or system breakdowns beyond working hours

Educational Qualification:

2–4 years of experience in pharmaceutical/API industry

Experience in regulated environment (EDQM/USFDA) preferred

Required Skills:

• Knowledge of GMP, Data Integrity, 21 CFR Part 11, Annex 11
• Hands-on experience in hardware, networking, and troubleshooting
• Familiarity with ERP systems and QC instrument software
• Basic understanding of Computer System Validation (CSV)
• Good documentation and audit handling skills

Ability to work independently in small setup

High level of integrity and compliance mindset