Beschreibung
Short Description:Support for CAPA process on site Zuchwil, Selzach, Bettlach, Grenchen, Oberdorf, Waldenburg, Hägendorf.
In order to specify: support the owners and the site CAPA Coordinator team for
-appropriate Investigation and
-Root Cause Analysis,
-definition of appropriate actions (corrections, corrective actions, preventive actions) with including
-the required documentation according to regulation 21 CFR .
The CAPAs deals with nonconformances regarding Quality systems, design and manufacturing.
Candidates have to have following expertise/knowledge:
- industrial practice in CAPA process in medical device or pharmaceutical industry
- knowledge of regulation and standards like ISO 13485, 21 CFR 820
- German speaking
further it would be terrific if the candidate would have:
-experience in Six Sigma (Black Belt/ Green Belt)
- technical education (engineering degree)