IT Quality Manager

Location Amsterdam
Discipline: Biotechnology
Contact name: Aimee Brenner

Contact email: a.brenner@panda-int.com
Job ref: 17915
Published: 4 months ago

For one of our top Biopharma clients we are looking for a IT Quality Manager Consultant.

Who can take on a broad range of activities to support the IT Department

Responsibilities:

Change Management

  • Facilitate and ensure the traceability of any change (GxP and non GxP) within existing systems (QMS and Topdesk)
  • Ensure information regarding changes is communicated to the customer
  • Issue Service Advisory notification of any downtime as a consequence of a change
  • Monitor all changes in the IT landscape as initiated by suppliers
  • Ensure change control procedures are followed
  • Chair and contribute to Change Advisory Board Meetings

IT Quality Management

  • Act as the GMP & CSV IT expert in the team
  • Ensure that all IT procedures are compliant with GAMP 5
  • Support with validation activities, supplier audits

Problem Management

  • Ensure Problems and Major Incidents are permanently fixed, root cause are proactively identified, documented and perform trend analysis
  • Chair and contribute to Incident Root Cause Analysis & Problem review meetings

Profile:

  • Change management experience
  • Affinity with IT quality aspects including CSV and GAMP 5
  • Experience within GxP environment is desired
  • Strong communication skills in English and preferably in Dutch

Practicalities:

  • 6 month contract (high chance of extension)
  • Location: Amsterdam
  • Start date: as soon as possible

For more info, please contact Aimee Brenner at +31 20 20 44 502 or at a.brenner@panda-int.com.