Beschreibung
Momentan suche ich einen Freiberufler für ein Pharmazieunternehmen mit Sitz in Hessen.IVD / AUDIT Senior Consultant
The consultant (business contractor) need to check the process of IVD product realization according to ISO 13485 chapter 7. This encompasses in particular R&D processes, raw material puchasing, manufacturing, marketing. The concerned functions are those involved in the aforementioned processes. The aim of the mock audit is to assess our processes and QM-systems for fitness for official authority audits. The consultant has to have profound knowledge and experience in auditing the related areas and QM-regulations.
Start date 30.05.2016
End date 31.07.2016
On-Site: 100%
If you are interested do not hesitate to contact me!
Kind regards
Languages
English
+++ business fluent
German
+++ business fluent
Non-IT Skills
Authorization for and proven experience in auditing IVDs
+++ (excellent), > 6 yrs.
In-depth knowledge of QM-regulations, in particular of ISO 13485 and related reg.
+++ (excellent), > 6 yrs.
Professional experience in QM and production of IVDs
+++ (excellent), > 6 yrs.
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