JOB DESCRIPTION (JD)

Job Title: IT Executive / IT Officer

Department: Information Technology

Location: Kurkumbh

Industry: API Pharmaceutical Manufacturing

Reporting To: Plant Head / QA Head

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:

Bachelor’s Degree in IT / Computer Science / BCA / MCA / B.E. (IT/Computer)

Experience:

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

Key Competencies:

Problem-solving and analytical skills

Ability to work independently in small setup

Good communication and coordination skills

High level of integrity and compliance mindset