Description
We are looking for a
Cloud Qualification Consultant (m/f)
Reference: -en
Start: asap
Duration: 3 MM+
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Understanding of the business requirements for a platform from the perspective of the owner of a GxP relevant, validated application
- Understanding of the various predicate rules driving the various platform qualification requirements
Your qualifications
- Experience with Validating GxP relevant applications in a vendor Cloud environment
- Experience with managing a large Cloud based validation/qualification projects
- Experience in defining a GxP qualification strategy and plan for a large Cloud based infrastructure/platform
- Experience with performing a vendor evaluation and defining a governance model between Novartis and a cloud provider such as Microsoft
- Comprehensive regulatory compliance knowledge (FDA, EU, MHRA, ICH) and practical application to the GxP regulations regarding computerized systems and platforms, including 21CFR Part11 and EU Annex 11
- Strong understanding of the MS SharePoint platform including O365, Yammer, SP2013 and MS Azure and the various implication from a data integrity, security and privacy perspective in relation to a large pharmaceutical organization
Skills:
- IT consultant