Beschreibung
On behalf of our client in the Life Science industry, Harvey Nash is looking for a Senior CAPA Consultant for a 4+ month project in Switzerland/area Solothurn.
The role includes coord.
You will be responsible for:
ensuring the availability of an overview of all CAPAs (corrective and preventive actions) and supporting users & stakeholders in the factory consultancy and guidance of all employees regarding CAPA requirements (external and internal) training and motivating the involved employees in the CAPA process-monitoring of work reporting to the QPM Manager regarding all progress and obstacles bringing in of improvement proposals, which increase the productivity and efficiency of the CAPA-process and providing active support to reach the settled goals knowing and following the guidelines with regard to codes of conduct, ethics and compliance programs, as well as other relevant Regulations especially ISO 13485, 21 CFR 820 making sure that CAPAs in accordance with regulatory requirements (ISO 13485, 21 CFR 820) and internal requirements to be implemented assisting in NCR and DCR/DCO; develop a risk assessment developing evaluation of errors and NCR at the factory, as well as improvements We require
practice and full understanding of CAPA process in medical device or pharmaceutical industry knowledge of regulation and standards like ISO 13485, 21 CFR 820 technical education (engineering degree) or extensive experience in the relevant field of expertise Competency Level: Senior Fluent in German is a must and fluent in English Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred).
For further details feel free to call me. Im looking forward to receiving your application.
