IT/OT Validation Partner - Maternity Cover

Category: Digital & IT

Location:Gentofte, Capital Region of Denmark, DK

• Lead the implementation of IT and automation solutions on small to large projects.

• Act as validation and compliance advisor for projects and continuous improvement efforts.

• Oversee or support the development and delivery of complete validation packages (e.g., IT Risk Assessments, URS, VPL/VPR, x VP/R).

• Collaborate with QA, IT, business teams, and vendors to execute computer system validation activities.

• Participate in inspections and internal audits.

• Facilitate verification and validation activities, including test execution, documentation review, and approval.

• Optimize, develop, and implement work processes and strategies for business advantages.
  
  

• Relevant educational background or strong Pharma/Life Sciences compliance experience, particularly with validated computer systems.

• Experience with Azure Dev Ops, software development, and automated/scripted testing.

• Knowledge of pharmaceutical Quality Management and Gx P systems.

• Familiarity with global regulatory guidelines (e.g., FDA, MHRA) and standards like FDA 21CFR Part 11, GAMP, Annex 11, and Data Integrity guidance.

• Strong project management skills and ability to manage complex tasks.

• Excellent communication skills in both Danish and English, with a proactive, team-oriented mindset.