IT Executive

Immacule Life Sciences; Solan; On-site; INR 300,000 - 420,000; Full time

Job summary

Immacule Life Sciences in Solan, Himachal Pradesh, seeks an IT Application Support professional to provide second-level support for IT applications, manage user accounts, and coordinate with vendors. The role covers incident management, QMS compliance, SOP documentation, backup testing, and system lifecycle support, with emphasis on GMP-aligned processes.

You will work with cross-functional teams to ensure secure, compliant IT operations and maintain records for audits.

Responsibilities

• IT applications second-level support and troubleshooting incidents.
• Coordinate with vendors for upgrades, patches and enhancements.
• Maintain IT support records and resolution documentation.
• Assist in system implementation, configuration and change activities.
• Create, modify and deactivate user accounts per approved requests.
• Manage user access based on roles and responsibilities; conduct access reviews.
• Record and track IT incidents, problems and service requests; initial investigations.
• Coordinate with IT teams and vendors for resolution; ensure closure with evidence.
• Support IT-related QMS activities: deviations, CAPA, investigations, change controls, risk assessments, periodic reviews.
• Ensure IT activities align with SOPs and GMP requirements; assist audits and data integrity.
• Prepare, review and maintain IT SOPs, work instructions and records.
• Monitor backup activities; coordinate verification and restoration testing; document results.
• Support change control, system lifecycle, and regulated-system changes with vendors/QA.
• Prepare IT compliance evidence for GMP audits, regulatory inspections and internal audits.
• Track audit observations and close actions in a timely manner.

Job description

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.