IT Executive

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