Beschreibung
Task:- Support for CAPA process on site.
- 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 non-conformances regarding Quality systems, design and manufacturing.
Requirements (Must have):
- Industrial practice in CAPA process in medical device or pharmaceutical industry
- Knowledge of regulation and standards like ISO 13485, 21 CFR 820
- Fluent in German/English
Nice to have:
- experience in Six Sigma (Black Belt/ Green Belt)
- technical education (engineering degree)
Beginn: 07.08.2013
Dauer: 31.12.2013
Branche: Medizin/Healthcare