IT Executive
Share
Job Location:
Monthly Salary:
Experience Required:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
Bachelors 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:
24 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
Ability to work independently in small setup
High level of integrity and compliance mindset
Required Skills:
Required Skills & Qualifications Bachelors degree in Information Technology Computer Science or related field (or equivalent experience) 13 years of experience in IT project coordination or project support Basic understanding of IT systems software development or infrastructure Familiarity with project management tools Strong organizational and time-management skills Excellent written and verbal communication skills Ability to work with cross-functional teams Preferred Qualifications Experience working in enterprise or multi-project environments Key Competencies Attention to detail Problem-solving skills Stakeholder coordination Documentation and reporting Ability to manage multiple priorities Reporting To IT Project Manager
