IT Responsible – Validation & Compliance Lead for HAC Cold Storage (Pre-FAT/SAT)

We are seeking an experienced IT Responsible to lead the pre-FAT and pre-SAT phase for a Cold Storage project. You will drive completion of ITRA, ensure IT compliance for DQ and VPL, and secure readiness for FAT/SAT activities. The role requires strong coordination with SMEs, suppliers, and validation teams to maintain full traceability, documentation quality and adherence to GxP and IT policies. A client-specific IT Responsible certification is mandatory.

TopSkills

• IT Risk Assessment (ITRA)
• Validation documentation (DQ, VPL)
• FAT/SAT readiness
• GMP / GxP compliance
• IT/OT architecture
• Stakeholder & vendor coordination
• Documentation & audit traceability