Assistant Manager

Key Responsibilities

• Design, implement, maintain, and support site IT infrastructure, systems, applications, and end-user devices.
• Monitor system performance and availability to ensure reliable operation of business-critical and GxP computerized systems.
• Troubleshoot hardware, software, network, database, interface, and application-related issues.
• Manage integration of computerized systems with IT infrastructure, databases, interfaces, and reporting applications.
• Administer user accounts, access privileges, and periodic access reviews in accordance with approved procedures.
• Implement and maintain cybersecurity controls, including endpoint protection, patching, vulnerability remediation, and system hardening.
• Monitor system backups and support restoration testing, disaster recovery, and business continuity activities.
• Ensure IT systems comply with GMP, data integrity principles, including ALCOA+, and applicable regulatory requirements.
• Provide technical support for the site GxP computerized systems validation program.
• Ensure validated computerized systems remain in a controlled state throughout their lifecycle.
• Review validation protocols, reports, QMS records, technical documents, and other system-related deliverables.
• Initiate, assess, and support timely closure of IT-related change controls, deviations, incidents, investigations, and CAPAs.
• Perform technical investigations and root cause analysis for system failures, recurring incidents, and compliance gaps.
• Maintain IT SOPs, work instructions, system inventories, configuration records, licenses, and technical documentation.
• Support internal audits, customer audits, regulatory inspections, self-inspections, and associated remediation activities.
• Coordinate with Production, QA, QC, Engineering, Automation, CSV, Information Security, Corporate IT, and external vendors.
• Support system upgrades, technology assessments, proof-of-concept initiatives, and digital transformation projects.
• Provide technical support and training to users and cross-functional team members on IT systems, cybersecurity, and data integrity requirements.
• Ensure timely completion of assigned IT operational, compliance, project, audit, and QMS action items.