Senior QA Sterility Assurance

Vor 3 Tagen

Lengnau, Schweiz TN Switzerland Vollzeit

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Responsibilities:
  • Have quality oversight of all sterility assurance and microbial related topics in Lengnau site.
  • Responsible for setting up the overall microbial control concepts on the Lengnau site.
  • Ensure the review and approval as a quality function for protocols, reports, procedures, and other relevant documents required for contamination control strategy, contamination investigation, and sterility hold time validation activities.
  • Contribute to the implementation of Lifecycle Validation concepts at Lengnau and act as the Subject Matter Expert for the area of responsibility during health authority inspections and customer audits.
  • Perform environmental monitoring to ensure sterility in manufacturing areas.
  • Investigate and resolve sterility-related issues.
Requirements:
  • Master's Degree in Microbiology or equivalent experience in the field.
  • Proven experience (minimum 3 years) in microbiology in the pharmaceutical industry.
  • Strong knowledge of sterility assurance principles and regulations.
  • Exceptional attention to detail and analytical skills.
  • Excellent communication and collaboration abilities.
  • Language: Fluent English required, with some proficiency in German beneficial (written and spoken).

Join Thermo Fisher Scientific Inc., Lengnau and be part of a highly ambitious team that is committed to delivering world-class products.

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