Job Summary

Responsible for site-level IT infrastructure administration, Computer System Validation (CSV), SOP life cycle management, and technical audit support to ensure compliance with GMP/GLP regulations and organizational standards.

Key Responsibilities

IT Infrastructure & Data Center Management:

- Perform daily, weekly, and monthly system backups, data restore verifications, and CAPA/deviation logging for failed backups.
- Monitor server performance, CPU/RAM usage, free disk space, and physical data center conditions (temperature, alarms).
- Maintain UPS systems, local air conditioning units, OS patches, antivirus definitions, and workstation upkeep.
- Manage LAN/WAN connectivity, Active Directory, corporate email coordination, hardware/software inventory, and IT procurement.
- Computer System Validation (CSV) & QC Support:
- Prepare protocols, execute validation, and draft reports for servers, computers, and laboratory software (Chromatography and Non-Chromatography systems like Empower & Chromeleon).




- Manage change controls, deviations, user access (creation, deactivation, password resets), and logbooks.
- Troubleshoot connectivity issues between lab hardware and software, coordinating with vendors for logs, patch management, and security controls.

SOP Life Cycle & Training:
- Draft, review, and maintain IT SOPs and the site master list.
- Conduct IT SOP training for quality users and attend internal GMP, GLP, and QA-related trainings.

Audit Support & Compliance:
- Face internal, regulatory (e.g., USFDA), customer, and corporate compliance audits.
- Provide pre- and post-audit support for Quality and Manufacturing departments.

IT Operations & Applications:
- Oversee expense budgeting, vendor AMCs, manpower management, and ticket resolution.
- Support enterprise applications including Trackwise, DMS, Track & Trace, and Chromeleon.

📌 IT Infra Project Manager (Ankleshwar)
🏢 Wockhardt
📍 Ankleshwar