Capa Legacy Review Consultant

Basel-City  ‐ Vor Ort
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Schlagworte

Beschreibung

CAPA Legacy Review - 6 Months - ASAP - 100% client based

JOB PURPOSE:

Perform NC Legacy Reviews 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:

* Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
* 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 process SMEs

QUALIFICATIONS & EXPERIENCE

* Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
* Working knowledge of Quality System Regulations.
* A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
* Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
* Demonstrated knowledge of business impact of compliance issues and risk management
* Proven ability to build partnerships both internally and externally

If you interested in this position, I´m looking forwart to hearing from you.

Campaign Ref: CH

To find out more about Real please visit www.realstaffing.com
Start
09/2013
Dauer
6 Months
Von
Real Staffing
Eingestellt
03.09.2013
Projekt-ID:
592548
Vertragsart
Freiberuflich
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