Auftrag A4979 - QA Project/Process Quality Manager GxP (contract)

Beschreibung

Projekt Nr.: A4979
Startdatum: sofort
Branche: Pharmaunternehmen
Dauer: 8 Monate mit Option
Einsatzort: Basel
Publiziert am: 07.10.2015

https://www.ghrgroup.ch/de/kandidaten/vakanzen/details/orderNr/A4979.html

Beschreibung
Für unseren Kunden suchen wir einen sehr erfahrenen QA Project/Process Quality Manager GxP wie folgt(English):
? The key project that this person will support is to provide QA eCompliance oversight as we migrate data and computer systems to other companies that have purchased them along with their associated Business Processes. In addition to this, the transitional situation requires temporary QA oversight as continue to operate the systems as well.

Hauptaufgaben
? To provide QA support for GxP impact computer system implementation projects. This means ensuring that projects, systems, and processes, meet the requirements of the clients Quality Manual.
? To provide excellent QA Operational support to IT departments. This includes assistance with GxP decision making, change control review and approval, SOP review and approval, and review/approval of other GxP related deliverables as needed.
? As the client continues to centralize its computer systems and services, the person in this role will assist with the development and implementation of typical CSV related SOPs and WIs.
? To help drive Quality into IT business processes wherever possible.
? To assist with the review and comment of existing IT CSV-related templates
? To assist with any other typical QA eCompliance responsibilities as required.
Key Requirements
? It is anticipated this person would have signature au-thority so they must have at least 7 years in a GxP en-vironment with a thorough understanding of:
? Computer Validation
? Validation of cloud solutions a plus
? 21CFR, Part 11
? EU Annex 11
? Typical IT processes
? Current trends in industry related to data integrity
? GAMP5 and its full lifecycle
? Project management
? SAP

Anforderungen
? Qualitäts Manager ein Muss
? GxP ein Muss

Sprachen
?Englisch sehr gut sehr gut ein Muss
?Deutsch gut gut von Vorteil

Wir freuen uns auf Ihre Bewerbung

André van Sprundel
CEO

GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG

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