IT Administration Executive

Key Responsibilities

• Provide IT support for bioanalytical systems and end users
• .Participate in system/software validation activities, execution, and documentation.
• Manage IT server and system backup and restoration as per approved SOPs. • Perform and document weekly, monthly, and yearly backups, including backup integrity verification.
• Manage and support IT incidents and response activities in coordination with QA, other stakeholders, and vendors.
• Review and update IT SOPs, including amendments and revisions, and coordinate departmental review and approval.
• Initiate and manage Change Control, Deviation, and CAPA processes for IT-related activities.
• Maintain and archive logbooks, forms, formats, PTRs, and other IT records.
• Support system/data restoration and IT requirements during sponsor, customer, and regulatory audits.
• Provide IT support for servers, storage, hardware, software, and user applications as required.
• Support FTP site creation, access management, data transfer, and troubleshooting.
• Manage project folders, access rights, and project data archival. Monitor server and storage disk space and take preventive action where required.
• Provide Helpdesk and ICT support and coordinate issue resolution with vendors.
• Lead and coordinate IT activities and support team management. Regulatory & Compliance Knowledge
• US FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5 Guidelines
• Computerized System Validation (CSV)
• Data Integrity and Good Documentation Practices
• Change Control, Deviation, CAPA, and Incident Management