Role & responsibilities

1. IT Application Support

- Provide second-level support for IT applications and computerized systems.
- Troubleshoot application-related incidents, problems and service requests.
- Coordinate with application vendors for technical issues, upgrades, patches and enhancements.
- Maintain application support records and issue-resolution documentation.
- Support system implementation, configuration and change activities.

2. User Account & Access Management

- Create, modify, disable and deactivate user accounts as per approved requests.
- Ensure user access is provided based on approved roles and responsibilities.
- Maintain user access records and periodically support access review.
- Ensure timely removal of access for transferred or separated employees.

3. Incident, Problem & Service Request Management

- Record and track IT incidents, problems and service requests.
- Perform initial investigation and troubleshooting.
- Coordinate with relevant IT teams and vendors for resolution.
- Ensure incidents are closed with appropriate evidence and documentation.
- Support investigation of recurring incidents and identification of root causes.

4. QMS & Compliance

- Support IT-related QMS activities, including:

- Deviations

- CAPA

- Incidents

- Investigations

- Change Controls

- Risk Assessments

- Periodic Reviews
- Ensure IT activities are performed in accordance with approved SOPs and applicable GMP requirements.
- Support compliance with applicable computerized-system and data-integrity requirements.
- Provide IT evidence and records during internal, customer and regulatory audits.
- Track and close IT-related audit observations and compliance actions.

5. SOP & Documentation Management





- Prepare, review and maintain IT SOPs, work instructions, formats and records.
- Ensure IT activities are performed according to approved procedures.
- Maintain controlled IT documentation and compliance records.
- Support periodic review and revision of IT SOPs.
- Maintain documentation for applications, infrastructure, access control, backup/restore and other critical IT systems.
- Ensure appropriate documentation and evidence are available for audit purposes.

6. Backup & Restoration

- Monitor and maintain backup-related records.
- Coordinate scheduled backup verification and restoration activities.
- Execute or support backup restoration testing as per approved procedures.
- Maintain restoration test reports and supporting evidence.
- Investigate backup failures and coordinate corrective actions.
- Ensure backup and restoration activities comply with approved IT procedures.

7. Change & System Lifecycle Support

- Support IT Change Control activities for application, infrastructure and computerized-system changes.
- Assist in impact assessments and risk assessments.
- Maintain documentation for system upgrades, patches, configuration changes and replacements.
- Coordinate with vendors and QA for regulated-system changes where required.
- Support validation/qualification documentation where applicable.

8. Audit & Inspection Support

- Prepare IT compliance evidence for:

- GMP audits

- Regulatory inspections

- Customer audits

- Internal audits

- IT audits
- Support retrieval of system logs, access records, backup records, SOPs and other required evidence.
- Track audit observations and ensure timely completion of assigned actions.

Preferred candidate profile

📌 IT Executive (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh