IT Solution Manager – GxP Compliance and Validation
Summary
Contract role via emagine supporting IT compliance and validation for projects at a pharmaceutical manufacturing site near Copenhagen: leading IT risk assessments (ITRA), preparing compliance deliverables like ITPSE and disaster recovery plans, reviewing DQ/VPL documents, and facilitating workshops across IT, automation, quality and suppliers.
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