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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
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