Beschreibung
- Support in computer validation acc. To FDA/GxP- knowledge of regulatory requirements of computer
validation acc. to FDA and GxP (especially GMP, GLP)
- technical consulting / project support to IT infrastructure
qualification (hosting)
- support in developing a concept for GxP conforming
operation and support of IT application
- enhancement of the existing IT SOP framework
- realization of a GxP knowledge platform
- re-alignment of document management processes
- support in design of qualification documents
- quality assurance in change management
Anforderung:
- in total 2 consultants needed:
1 senior consultant and 1 junior consultant
- experienced in IT strategy & consulting
- expert in IT risk management
- expert in process data modelling & technical writing
- experienced in project management
- expert in ITIL & service management
- expert in process consulting
Language skill: English, German (both fluent)
Duration: , fulltime, in total 12 months
extension option
Budget:
Senior Consultant: EUR ca. 85,00 all in MA/LU,
Junior Consultant EUR ca. 60,00 all in
Projektstart: 1.5.2014
Projektende: Mai 2015 + extension option
Auslastung: 100%
Leistungsort: Mannheim/Ludwigshafen area
Direktbewerbung: hier