IT Solution Manager – GxP Compliance and Validation

emagine; København; In loco; DKK 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

emagine Group, on behalf of a client in the pharmaceutical industry, is seeking an IT Solution Manager to support IT compliance and validation activities for projects at a manufacturing site near Copenhagen.

You will lead IT risk assessments, identify IT assets and interfaces, complete IT compliance deliverables, review DQ and VPL, and facilitate cross-functional workshops to ensure GxP and audit readiness.

Competenze

• Experience in IT risk assessments and IT validation documentation.
• Ability to review DQ and VPL documents from IT perspective.
• Experience in regulated environments and GxP compliance.
• Knowledge of industrial IT environments, networks and cybersecurity.

Mansioni

• Lead IT risk assessments for projects at a manufacturing site.
• Identify IT assets, interfaces, risks and mitigations.
• Complete IT compliance deliverables including ITPSE and Disaster Recovery Plans.
• Review DQ and VPL documents from IT perspective.
• Ensure documentation traceability of IT requirements and tests.
• Facilitate workshops across IT, automation, quality, facilities and suppliers.
• Support IT readiness for FAT and SAT activities.
• Maintain records per GxP and audit requirements.

Conoscenze

GxP knowledge

IT risk assessment

IT validation

DQ/VPL review

Cybersecurity awareness

Stakeholder management

Workshop facilitation

Regulated environment experience

Documentation skills

GDPR awareness

Descrizione del lavoro

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