Beschreibung
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.
