permanent role – remote – Switzerland or Gemany based
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this exciting journey through the auditing of apheresis collection centers, the sites where a patient’s blood is withdrawn, packaged, and shipped according to specified procedures.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.
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