GxP IT Compliance & Validation Lead

emagine Group; 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

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.