NC Capa Legacy Review Consultant

Vertragsart:
Vor Ort
Start:
08/2013
Dauer:
4 Months
Von:
Real Staffing
Ort:
Solothurn
Eingestellt:
27.08.2013
Land:
flag_no Schweiz
Projekt-ID:
588932

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NC CAPA Legacy Review Consultant - Switzerland

I am currently seeking a NC CAPA Legacy Review Consultant for a global top ten Medical Devices Company to perform NC Legacy Review per protocol, to ensure adequate review of NC product and process risk.

MAIN DUTIES & RESPONSIBILITIES:
* Perform NC Legacy Reviews per protocol per schedule.
* Engage with local NC and site process SMEs to ensure adequate review of NC product and process risk
* Alert management of product quality & compliance issues for proper and timely escalation to CAPA.
* To adhere to the company's procedures as detailed in the SOP manual

KEY COMPETENCIES REQUIRED:
* Expert knowledge of the US Quality System Regulations and ISO 13485
* Demonstrated track record of delivering best in class results in the Quality Systems area
* Fluent in German and in English - able to review NC documents & interact with NC & site
* Additional fluency in Italian is an advantage
* Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
* Working knowledge of Quality System Regulations.
* Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards

If you are interested in this project or need further information please send your CV directly to Marcus Müller, at m.muller(at)realstaffing.com. You can also call me on +41 (0)

Keywords: NC Capa Review, product and process risk, SMEs, SOP, FDA QSR, ISO , Medical Devices, German and English,Switzerland, Freelance

Campaign Ref: CH

To find out more about Real please visit www.realstaffing.com