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Un auditeur est un conseiller d'entreprise. Les auditeurs pouvant travailler aussi bien pour une société d'audit que pour de grosses entreprises dans l'économie, la technologie et l'industrie, on différencie les auditeurs internes et externes. Dans les deux cas, l'auditeur mène des audits, c'est-à-dire qu'il analyse la rentabilité des structures et du fonctionnement d'une entreprise. Pour exercer le métier d'auditeur, il faut une formation d'économie d'entreprise axée principalement sur la compatbilité, la révision et le controlling. De plus, deux à trois ans d'expérience dans un commissariat aux comptes et un stage à l'étranger sont très souvent exigés. Des auditeurs sont recherchés dans toutes les entreprises et tous les secteurs. Vous trouverez des postes d'auditeurs sur toutes les bourses d'emploi suisses.

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QA Auditor ? Cell Therapy ? Blood & Tissue GMP regulations

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Avis soumis
gloor & lang ag life science careers
permanent role – remote – Switzerland or Gemany based
QA Auditor ? Cell Therapy ? Blood & Tissue GMP regulations
Our customer is an innovative biopharmaceutical Big Pharma company with major subsidiaries in Switzerland. Specialized in immunotherapy and being one of the biggest innovators in the field of cell therapy with an attractive portfolio of marked products. In oncology, cell therapy is at the epicenter of personalized medicine. This exciting opportunity will give you the opportunity to support the innovative expansion of cell therapies into European markets, for clinical and commercial purposes. 

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this exciting journey through the auditing of apheresis collection centers, the sites where a patient’s blood is withdrawn, packaged, and shipped according to specified procedures.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.
You will write audit reports within provided timelines, issuing reports along with Audit Findings Response Plans and/or Audit Closure Memos. You assess responses to audit observations and report all related metrics associated with each audit. In collaboration with management, you lead the grading of observations and the identification of observation and effectiveness check requirements, ensuring that differences in opinion are resolved. You are adept in resolving schedule issues and escalate issues where appropriate.Your profile:
  • 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. 
You are confident and self orgnised to lead audits as required. The position can be effected remotly, as the travel load is up to 50%, mainly in European countries with occasional travelling to Asia and the US.

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/

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