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Manager - QA Project/Process Quality Manager
Eingestellt von BRINE SA
Gesuchte Skills: Consultants
Projektbeschreibung
JOB DETAILS
Cloud Qualification Resource Profile
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
WORK LOCATION, PERMITS REQUIRED, DURATION, WORKLOAD, LANGUAGE
° Basel
° EU citizen or valid work permit
° 19.05.2014 - 31.08.2014
° 100%
° English, German
BRINE BESCHRIEB
BRINE SA places the customer needs firmly in the centre and offers a speedy and professional solution. We carefully select suitable consultants and IT-specialists on the basis of their qualification. We pay particular attention to their education, business and technical knowledge, professional experience, individual character and not least, personal preferences
Are you the skilled and experienced Person to fulfil the requirements and are you interested in this position ?
If yes send me your Curriculum Vitae
Cloud Qualification Resource Profile
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
WORK LOCATION, PERMITS REQUIRED, DURATION, WORKLOAD, LANGUAGE
° Basel
° EU citizen or valid work permit
° 19.05.2014 - 31.08.2014
° 100%
° English, German
BRINE BESCHRIEB
BRINE SA places the customer needs firmly in the centre and offers a speedy and professional solution. We carefully select suitable consultants and IT-specialists on the basis of their qualification. We pay particular attention to their education, business and technical knowledge, professional experience, individual character and not least, personal preferences
Are you the skilled and experienced Person to fulfil the requirements and are you interested in this position ?
If yes send me your Curriculum Vitae
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Organisation/Management