IT Executive (Kurkumbh)

IT Executive (Kurkumbh)

17 Aug
|
Leading
|
Kurkumbh

17 Aug

Leading

Kurkumbh

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 setting (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





📌 IT Executive (Kurkumbh)
🏢 Leading
📍 Kurkumbh

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