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CAPA Consultant
Eingestellt von Berry Technical
Gesuchte Skills: Consultant, Consultants, Client
Projektbeschreibung
CONTRACT CAPA CONSULTANT - FORTUNE 500 COMPANY.ZUCHWIL/SWITZERLAND
Job Type: Contract - 3 - 6 months initially (likely to extend)
Salary: 90 - 100 CH per hour
Start: Immediately
Location: Zuchwil, Solothurn, Switzerland
THE ROLE:
Our client is a multinational, Fortune 500 company and is looking for several CAPA Consultants with a passion for technology to join their Swiss office (Zuchwil, Solothurn) to 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 OR Italian and 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
Job Type: Contract - 3 - 6 months initially (likely to extend)
Salary: 90 - 100 CH per hour
Start: Immediately
Location: Zuchwil, Solothurn, Switzerland
THE ROLE:
Our client is a multinational, Fortune 500 company and is looking for several CAPA Consultants with a passion for technology to join their Swiss office (Zuchwil, Solothurn) to 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 OR Italian and 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
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Organisation/Management