Description
Consultant - CAPA Legacy ReviewI am currently seeking a CAPA Legacy Review Consultant for a global top 5 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.
KEY COMPETENCIES REQUIRED:
* Fluent in German and in English - able to review NC documents & interact with NC & site
* 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
If this role could be of interested in this role, please send your CV including hourly rate expectation to Marcus Müller at Real.
Keywords: NC Capa Review, product and process risk, SOP, FDA QSR, ISO , Medical Devices, German and English, Switzerland, Freelance