Sr. IT Officer/ Executive

Senior IT Officer

Key Responsibilities:

1. IT Compliance and Documentation

• Draft, review, and maintain IT Standard Operating Procedures (SOPs), protocols, and related documentation.
• Ensure all IT processes comply with GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA++ principles.
• Participate in validation and periodic review of GxP computerized systems for Quality Control and Production.
  

2. Data Backup and Restoration

• Perform regular data backups and periodic restoration tests as per company policy and maintain records. .
• Handle backup applications and perform Bare Metal (OS image) backup and restoration activities.
  

3. User and Access Management

• Create and manage user IDs and project access in analytical software systems (e.g., Empower, Chromeleon).
• Manage user and group accounts for email systems, Google Workspace, and Microsoft 365
  

4. Network and System Administration

• Administer basic network components including firewalls, routers, VPNs, and access controls.
• Install, configure, and manage Microsoft Windows Server (2008/2012 R2/2016/2019) and client OS (Windows XP11).
• Perform Windows patch management, antivirus updates, and routine system health checks.
  

5. Application and System Support

• Provide administrative support for SAP B1 and SAP HANA environments.
• Support and coordinate vendor implementation of LIMS (Laboratory Information Management System) in analytical labs.
• Manage and support applications such as abSolutions, Empower, Chromeleon, SCADA/HMI, and other standalone or networked lab and production systems.
• Provide IT support for QMS, DMS, and LMS systems used in quality and training functions.
  

6. Technical Support and Troubleshooting

• Handle day-to-day IT issues and provide prompt technical support to end users.
• Coordinate with vendors for system maintenance, upgrades, and validation support.
  

7. Compliance and Validation Support

• Ensure that all GxP computerized systems are validated and maintained per GAMP 5 and regulatory requirements.
• Support audit and inspection activities by providing required IT documentation and compliance evidence.
• Participate in risk assessments and change control processes related to IT systems.

Candidate Profile:

• At least 2 to 3 years in a

  pharmaceutical or regulated industry

  with exposure to GxP environments.
• Proficiency in Windows Server, Active Directory, Networking, and Data Backup Management.
• Working knowledge of SAP (B1/HANA), LIMS, QMS, DMS, and LMS applications.
• Familiarity with laboratory and production automation software (e.g., SCADA, Chromeleon, Empower).
• Experience with firewall, VPN, and access control configuration.
• Understanding of GAMP 5, ALCOA++, 21 CFR Part 11, and Annex 11 requirements.