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.