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QA Contamination Prevention Manager

Ihre Herausforderung

  • Ensures that an end-to-end microbial control concept is developed for the biotechnological drug substance manufacturing facilities and is captured in local documents (incl. specifications, SOPs, etc.)
  • Supports the Quality Oversight on the activities of the Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view
  • Writes, Reviews and approves SOPs, deviation reports and change requests associated with the above-mentioned topics
  • Supports the preparation and follow-up of customer audits and regulatory inspections; acts as an expert during audits / inspections presenting aspects related to the microbial control and sterility strategies
  • Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences


Ihre Kompetenz

  • University degree (Bachelor, Master or PhD) in pharmacy, engineering, chemistry, or related life sciences discipline, preferably microbiology
  • More than 5 years (more than 10 years preferred) of experience in the area of biopharmaceutical manufacturing
  • Strong background in cGMPs
  • Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing, microbial control strategies
  • Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies (e.g. US FDA, EMA, etc.).
  • Languages: English Fluent and German as an advantage


Ihre Perspektiven

Arbeit in einem innovativen Unternehmen


Ihr Kontakt

Frau Malgorzata Rawicka, Trainee, beantwortet Ihre Fragen gerne unter der Nummer +41 58 233 2300.

Bitte bewerben Sie sich direkt online.

Beziehen Sie sich dabei bitte auf die Referenznummer 043-MLRA-180870-28-DE.
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Deadline: 09-06-2024

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