Job Description
IT Infrastructure, Security & CSV Lead ( Pharma Experience Mandatory) Key Responsibilities IT Infrastructure & Systems Management - Manage and maintain servers, desktops/laptops, operating systems, business applications, email systems, Active Directory, GPOs, NAS storage, and overall IT infrastructure. - Administer network infrastructure including firewalls, switches, Wi-Fi, user access, permissions, and software deployment. IT Security & Business Continuity - Implement and maintain IT security policies, access controls, CCTV systems, data protection, backup, disaster recovery, and business continuity plans. - Ensure data confidentiality, integrity, and availability across all systems. Vendor, Asset & Budget Management - Manage IT budgets, procurement, vendor relationships, contracts, and IT assets/licenses. - Maintain accurate inventory and asset tracking records. User Support & Compliance - Provide technical support, user training, and system administration. - Support regulatory/customer audits and ensure compliance with company policies and GxP requirements. Quality Management & CSV - Ensure compliance with GxP, QMS, GAMP 5, EU Annex 11, and 21 CFR Part 11 requirements. - Manage deviations, CAPA, change controls, risk assessments, and SOP development. - Lead Computer System Validation (CSV) activities, including URS, FRS, Validation Plans, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports, and system retirement activities. - Act as the Subject Matter Expert (SME) for CSV and validation lifecycle management. Key Skills - Windows Server & Active Directory Administration - Network Infrastructure & Cybersecurity - Firewall, Switch & Wi-Fi Management - Backup, Disaster Recovery & Business Continuity - GxP Compliance & Computer System Validation (CSV) - GAMP 5, EU Annex 11 & 21 CFR Part 11 - Vendor, Asset & Budget Management - SOP Documentation, CAPA & Risk Management - Team Leadership & User Training Skills: network administration & cybersecurity,gxp compliance & csv documentation,it security & governance