IT Solution Manager – GxP Compliance and Validation

Lokation: København

On behalf of a client in the pharmaceutical industry, we are looking for an IT Solution Manager to support IT compliance and validation activities for projects at a manufacturing site. Main Responsibilities Lead the scoping, preparation and completion of IT Risk Assessments (ITRA) Identify IT assets, interfaces, risks and required mitigation measures Complete IT compliance deliverables, including ITPSE and Disaster Recovery Plans Review and sign Design Qualification (DQ) and Validation Plan (VPL) documents from an IT perspective Ensure IT requirements, risk controls and testing activities are documented and traceable Facilitate workshops with stakeholders across IT, automation, quality, facilities and suppliers Support IT readiness for FAT and SAT activities Maintain documentation and review records in line with GxP and audit requirements Key Requirements Knowledge of GxP requirements Proven experience as an IT Solution Manager, IT owner or similar role in a regulated environment Hands-on experience preparing IT Risk Assessments and IT validation documentation Experience reviewing DQ and VPL documents Understanding of industrial IT environments, including networks, PLC/SCADA interfaces, servers, endpoints, backup and cybersecurity Familiarity with FAT and SAT processes Strong documentation, stakeholder management and workshop facilitation skills Knowledge of GDPR and cybersecurity practices for industrial systems is an advantage Other Details Assignment duration:1/12/2026 - 30/06/2027 Location: Gentofte

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