Denmark Job Openings

Skillspark AB

IT Validation Lead

Copenhagen

FULL TIME

September 23, 2024

Start
ASAP
Duration
10-12 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.

Responsibilities:

  • 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.

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 Gx P (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

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