Beschreibung
Harvey Nash is looking for a QM/IGM related to the qualification/validation of Cloud Services for a 3 + month project in Switzerland.
Requirements
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 Understanding of the business requirements for a platform from the perspective of the owner of a GxP relevant, validated application 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 Understanding of the various predicate rules driving the various platform qualification requirements Business experience in one of the primary businesses within the Pharma industry (eg, manufacturing, clinical development, quality control, etc.) Direct experience in providing these services to a large, multinational pharmaceutical company 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 Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
