QA Auditor ? Cell Therapy ? Blood & Tissue GMP regulations

You will support this exciting journey through the auditing of apheresis collection centers, the sites where a patient’s blood is withdrawn, packaged, and shipped according to specified procedures. This is a critical role that requires someone with demonstrated experience conducting audits in a regulated environment, familiarity with blood and tissue-related regulations such as ATMPs, JACIE, and/or familiarity with apheresis operations. You will be able to contribute towards an annual risk assessment exercise, proposing and implementing audit process improvements, and will cross-train to support GMP/GDP audits related to other vendors such as material suppliers, manufacturing organizations, analytical labs, and more.
- experience in pharmaceutical or biotechnology GMP/GTP regulated environment
- or 3+ years of healthcare experience directly related to apheresis-operations within a hospital or similarly regulated industry
- familiar with GMP and GTP regulations, documents and guidelines
- Strong communication skills (verbal and written) in German & English,
- Ability to travel up to 50% of the time, and at times, with limited notice
- You have some experience in QA auditing and ability to communicate to medical professionals in centers and hospitals. Due to your own professional or scientific background you have a deep understanding of the field of biotechnology and the cell therapy technology behind it.
Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre vollständige Bewerbung.
Adresse
gloor & lang ag life science careers
Frau Aline Fischer
Team Assistant
Bahnhofstrasse 31
5400 Baden
+41 61 206 61 81
Site web https://www.gloorlang.com/