IT Infra Project Manager

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.