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:

Bachelor’s 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

Requirements

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