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10100055 Fresenius Kabi Deutschland GmbH

Senior Manager Sterility Assurance(m/w/x)

Bad Homburg vor der Höhe
Full-timeOn-siteSenior
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Conducting site and lab assessments for pharmaceutical quality systems. Advanced degree and 10+ years pharma QA/QC experience required. Support for external assessments.

Requirements

  • Advanced degree (MSc or higher) in Biology or related field
  • At least 10 years of pharmaceutical QA/QC experience
  • Extensive knowledge of pharmaceutical quality systems and global regulatory requirements (EU GMP, WHO GMP, CFR, ISO 9001)
  • Strong understanding of microbiological processes and compliance (EU Annex 11, CFR Part 11)
  • Proven expertise in conducting inspections and audits in microbiological labs and aseptic manufacturing
  • International work experience and willingness to travel up to 50%
  • Excellent communication skills and English fluency
  • Strong teamwork, leadership, and proactive problem-solving abilities

Tasks

  • Conduct site and laboratory assessments
  • Document site and laboratory assessments
  • Support internal assessments
  • Conduct internal assessments
  • Support external assessments
  • Conduct external assessments
  • Audit suppliers
  • Audit contract laboratories
  • Advise production units on GMP gaps
  • Advise QA on GMP gaps
  • Advise QC on GMP gaps
  • Advise local site teams on GMP gaps
  • Strengthen local expertise
  • Lead global quality improvement projects
  • Support global quality improvement projects
  • Prepare training materials
  • Develop global SOPs
  • Review global SOPs
  • Enhance global SOPs
  • Develop global guidelines
  • Review global guidelines
  • Enhance global guidelines
  • Develop global template documents
  • Review global template documents
  • Enhance global template documents
  • Review site documents for microbiological processes
  • Review site documents for aseptic processes
  • Summarize microbiological quality metrics
  • Analyze microbiological quality metrics
  • Track deviations with sites

Work Experience

  • 10 years

Education

  • Master's degree

Languages

  • English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 100055 Fresenius Kabi Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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