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 Bharuch
🏢 Wockhardt
📍 Bharuch