IT Executive
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1. Job Purpose<\/b>:
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To manage and maintain IT infrastructure and computerized\nsystems in compliance with GMP,
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Data Integrity, and regulatory requirements (EDQM, USFDA,\nWHO), ensuring smooth plant
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operations and audit readiness.
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2. Key Roles & Responsibilities:<\/b>
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2.1 IT Infrastructure Management
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Maintain and support all IT assets including desktops,\nlaptops, servers, printers, and networking
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equipment
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Ensure proper functioning of LAN/WAN, internet, firewall,\nantivirus, and CCTV systems
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Perform installation, configuration, and troubleshooting of\nhardware and software
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2.2 Regulatory Compliance & Data Integrity
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Ensure compliance with 21 CFR Part 11, EU Annex 11, and\nALCOA+ principles
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Maintain user access control, audit trails, and system\nsecurity
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Support Computer System Validation (CSV) activities\n(IQ/OQ/PQ)
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Ensure all GxP systems remain validated and compliant
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2.3 QC Instrument Software Support
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Provide support for software linked to instruments like\nHPLC, GC, Malvern, UV
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Ensure proper data recording, storage, and retrieval
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Coordinate with vendors for maintenance and troubleshooting
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2.4 Data Backup & Security
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Perform and monitor regular data backups and restoration\nchecks
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Maintain backup logs and ensure data protection
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Implement cybersecurity measures to prevent unauthorized\naccess
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2.5 Documentation & Audit Compliance
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Prepare and maintain IT SOPs, policies, and records
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Maintain logs: backup, access control, change control, and\nincidents
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Support internal and external audits (EDQM, USFDA, WHO\-GMP,\ncustomer audits)
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Address audit observations and implement CAPA
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2.6 User Support & Training
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Provide IT support to all departments (QA, QC, Production,\nWarehouse, Admin)
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Install and configure required systems and applications
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Train employees on IT systems and data integrity practices
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2.7 Change Control & Incident Management
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Participate in change control for system upgrades and\nmodifications
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Handle IT\-related deviations, incidents, and CAPA
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2.8 Vendor Management
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Coordinate with external vendors for IT services, AMC, and\nprocurement
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Ensure timely service and system uptime
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3. Educational Qualification:
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Bachelor\u2019s Degree in IT / Computer Science / BCA / MCA /\nB.E. (IT/Computer)
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3. Authority & Responsibility:<\/b>
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Responsible for maintaining IT systems and ensuring\ncompliance
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Authorized to control user access and system security
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Responsible for IT documentation and audit readiness
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4. Working Conditions:<\/b>
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Based at manufacturing plant
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May require support during audits or system breakdowns\nbeyond working hours
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Requirements<\/h3>
Educational Qualification:<\/b> 2\u20134 years of experience in pharmaceutical/API industry Experience in regulated environment (EDQM/USFDA) preferred Required Skills:<\/b> Knowledge of GMP, Data Integrity, 21 CFR Part 11, Annex 11 Hands\-on experience in hardware, networking, and\ntroubleshooting 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
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