Manager – QA Project/Process Quality Manager – Level III – 19171-06

- 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
(e.g., 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

We are looking for QM/IGM related to the qualification/validation of Cloud Services

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Hours per Day 10
Hours per Week 60
Total Hours 900

Anforderung:
see above

Projektstart: 19.05.2014
Projektende: 31.08.2014
Auslastung: 100%
Leistungsort: Basel/St.Johann (CH)

Wir freuen uns auf Ihre Bewerbung oder über die Empfehlung eines(r) Kollegen(in). Bei Interesse senden Sie uns bitte unter Angabe der Projektnummer (19171-06) Ihren CV (Word-Datei) sowie Ihre Stundensatz, bzw. Tagesatzvorstellung für das ausgeschriebene Projekt.

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Projektanbieter: people4project GmbH

Bewerbungsschluss: 09.05.2014

Letzte Aktualisierung: 30.04.14

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