About the role
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