IT Executive
Indussystem, Coffeyville, KS, United States
Job Description
Job Title:
IT Executive / IT Officer
Department:
Information Technology
Industry:
API Pharmaceutical Manufacturing
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. 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.
3. 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.
4. QC Instrument Software Support Provide support for software linked to instruments such as HPLC, GC, Malvern, UV.
Ensure proper data recording, storage, and retrieval.
Coordinate with vendors for maintenance and troubleshooting.
5. 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.
6. 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.
7. 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.
Participate in change control for system upgrades and modifications.
Handle IT-related deviations, incidents, and CAPA.
Coordinate with external vendors for IT services, AMC, and procurement.
Ensure timely service and system uptime.
8. Work 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
Problem‑solving and analytical skills
Ability to work independently in small setup
Good communication and coordination skills
High level of integrity and compliance mindset
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IT Executive / IT Officer
Department:
Information Technology
Industry:
API Pharmaceutical Manufacturing
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. 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.
3. 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.
4. QC Instrument Software Support Provide support for software linked to instruments such as HPLC, GC, Malvern, UV.
Ensure proper data recording, storage, and retrieval.
Coordinate with vendors for maintenance and troubleshooting.
5. 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.
6. 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.
7. 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.
Participate in change control for system upgrades and modifications.
Handle IT-related deviations, incidents, and CAPA.
Coordinate with external vendors for IT services, AMC, and procurement.
Ensure timely service and system uptime.
8. Work 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
Problem‑solving and analytical skills
Ability to work independently in small setup
Good communication and coordination skills
High level of integrity and compliance mindset
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