Beschreibung
Expert Biocompatibility (m/f)
Reference: -en
Start: asap
Duration: 9 MM+
Main tasks:
- Build and maintain a database (Excel) to verify the completeness of biocompatibility and cleaning validation documentation of existing products for MDD compliance
- Perform detailed inventory gap assessments for MDD compliance (derived from existing guidelines and the underlying requirements of the ISO 10993 series of standards, ISO 17664 and additional recommendations from FDA guidance documents)
- Prepare product-specific biocompatibility assessments and compiling cleaning validation records (using existing test data of equivalent / similar products or other technical rationale)
- Create test specifications for biocompatibility testing and cleaning validation (incl. selecting and working with external partners to complete these tests)
- Final documentation of the test procedure in test reports (English), including independent evaluation of the final test results with regard to product safety
Main qualifications
- Completed studies in the field of Natural sciences - technical studies, organic chemistry or biology
- Experience with ISO 10993 and ISO 17664
- English (fluent)
Main advantages:
- Reputable company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
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