IT Validation Lead

at  Skillspark AB

STARTASAP

DURATION10-12 months
emagine is seeking an experienced IT Validation Lead (IT QC) for a client in the pharmaceutical industry to support a project focused on implementing a Real-time Monitoring & Automated Temperature Evaluation System. This system will be used for temperature monitoring and management of material transports in the distribution chain.

REQUIREMENTS:

• Strong experience in IT Quality Control (ITQC) with a focus on User Requirement Specification (URS).
• Proficiency in IT Risk Assessment and Validation/Implementation planning.
• Solid knowledge of Test Management and compliance with GxP (Good Practice) standards.
• Experience working with pharmaceutical distribution or logistics processes is a plus.
  Location: Bagsværd, Denmark (Hybrid)
  Start Date: ASAP
  End Date: 30-06-2025
  Allocation: Full time, time & material

• Execute deliverables based on Standard Operating Procedures (SOP) for IT systems and digital solutions.
• Develop and manage User Requirement Specifications (URS), IT Risk Assessments (ITRA), validation/implementation plans, and Test Management.
• Ensure compliance with Good Distribution Practice (GDP) guidelines throughout the project.
• Support the implementation and validation of a GDP-critical system within a supply chain logistics environment.