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CAPA Consultant

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Consultant, Client

Projektbeschreibung

On behalf of our client in the Life Science industry, Harvey Nash is looking for a CAPA Consultant for a 4+ month project in Switzerland/area Solothurn.

The role includes performing NC Legacy Reviews per protocol to ensure adequate review of NC product and process risk.
- You will be responsible for:
- Performing NC Legacy Reviews per protocol per schedule
- Engaging 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
- Adhering to the company's procedures as detailed in the SOP manual

We require

- 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
- Strong knowledge of quality and compliance for Medical Device Industry (GMP's)
- Working knowledge of Quality System Regulations, 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
- Competency Level: Normal
- Fluent in German and in English, Italian is desirable - able to review NC documents & interact with NC & site process SMEs

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to Moritz. For further details feel free to call me

Im looking forward to receiving your application.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    31.12.2013

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland