Process Quality Manager

REFERENCE NR.: 4820JK

INDUSTRY: Pharmaceutical

LOCATION: Basel und Region

START: 19/05/2014

DURATION: till 31/08/2014

ROLE: Our customer needs a QA Project/Process Quality Manager who is willing to go the extra mile.

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 our customer 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
- 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 and the various implication from a data integrity, security and privacy perspective in relation to a large pharmaceutical organization