IT Responsible — HAC Cold Storage (FAT/SAT Pre-requisites)

Role: Governance, risk and complianceSeniority level: ExpertLocation: Gentofte / Copenhagen (DK)Remote: 0%Assignment period01 Dec 2025- 31 May 2026Assignment descriptionWe are looking for an IT Responsible — HAC Cold Storage (FAT/SAT Pre-requisites) for our client in the pharma industryRole SummaryWe are seeking an experienced IT Responsible to support the HAC Warehouse Cold Storage project during the critical pre-FAT (Factory Acceptance Test) and pre-SAT (Site Acceptance Test) phase. The IT Responsible will lead IT-specific compliance and assurance activities required to progress to FAT and SAT, with primary responsibility for completion and sign-off of IT deliverables including the IT Risk Assessment (ITRA), Design Qualification (DQ) review and signature, and Validation Plan (VPL) review and signature.The role requires specific client IT Responsible training certification.Key ResponsibilitiesLead scoping and creation of the IT Risk Assessment (ITRA) Collaborate with project subject matter experts (SMEs) to gather inputs and define ITRA scopeIdentify IT assets, interfaces, risk scenarios and risk mitigation measures relevant to Cold Storage systemsProduce and maintain the ITRA document in line with Novo Nordisk standards and timelinesUpdate and finalise ITRA to enable scheduling of FAT and SATComplete the ITRA within project deadlinesDrive consultations and workshops with stakeholders to ensure timely completionEnsure the ITRA is traceable, auditable, and aligned with validation and quality requirementsReview and sign-off IT-related validation documents Review Design Qualification (DQ) for IT impacts and provide formal IT Responsible signatureReview and sign the Validation Plan (VPL) from an IT perspectiveEnsure all IT-related requirements, risk controls and test strategies are reflected in DQ and VPLStakeholder engagement and coordinationWork closely with project SMEs (controls, automation, facilities, quality, suppliers) to ensure IT requirements are captured and addressedLiaise with suppliers and vendors to clarify IT interfaces and responsibilitiesProvide input to scheduling for FAT and SAT based on IT readinessCompliance, documentation and traceabilityEnsure all IT deliverables meet the client's policies, validation and GMP requirements Maintain clear records of reviews, decisions and signatures for audit readinessRequired qualifications and experienceClient specific IT Responsible training certification (mandatory)Proven experience as IT Responsible, IT owner, or equivalent role supporting validation activities in regulated environments (pharmaceutical, biotech, food)Experience preparing or reviewing ITRA / IT risk assessments and validation documentation (DQ, VPL, IQ/OQ/PQ experience desirable)Strong understanding of IT architecture for industrial/automation environments (networking, PLC/SCADA interfaces, servers, endpoints, backup, cybersecurity)Familiarity with FAT and SAT processes and requirementsExcellent stakeholder management, communication and facilitation skillsAttention to detail and strong documentation skillsDesiredExperience working with cold storage or warehouse automation systemsKnowledge of GxP, GDPR and cybersecurity best practices for industrial systemsWorking conditions and timeframeExpected to commence scoping and ITRA activities as soon as possibleFAT/SAT dates are to be scheduled and are dependent on ITRA finalisationStart date: 01-12-2025End date: 31-05-2026Location: Gentofte, Denmark Required skillsGRC (governance, risk management and compliance)Risk and ComplianceFAT and SAT processesPharmaITRA / IT risk assessments and validation documentationIT Responsible training certification LanguagesEnglish (Proficient) Additional detailsHours per week: 30