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Open nowPosted 45 days ago

Manager Sterilty Assurance (m/w/x)

job-room.ch119,207 open roles

Where
Berne, BE, Switzerland
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Your applicationOpen nowManager Sterilty Assurance (m/w/x)job-room.ch · Berne, BE, Switzerland

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10.5% of postings close within 7 days. Measured by our own scanner across the market. job-room.ch postings stay open a median of 5 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted 45 days ago

job-room.ch median: 5 days open

The posting

Für die lokale Sterility Assurance Organisation am Standort Bern suchen wir eine erfahrene Fachperson im Bereich Sterilitätssicherung. Sie übernehmen im Rahmen der Projekte und Risikoanalysen die Verantwortung als "Function Owner" und berichten direkt an den Site Leader (m/w/d):

Manager Sterility Assurance (m/w/x)

(zunächst befristet auf 2 Jahre)

Kompetenzen und Verantwortlichkeit:

 

  • Erstellung und SME für Prozess-Risikoanalysen als Sterility Assurance Experte bezüglich Kontaminationsrisiken
  • Identifizierung und Umsetzung von Verbesserungen in den aseptischen Prozessen sowie Koordination der nötigen Aktionen und Überwachen des Fortschritts
  • Erstellung oder Aktualisierung von SOPs, Arbeitsvorschriften und Berichten (APS, Monitoring) welche den Fachbereich Sterilitätssicherung betreffen
  • Verantwortlicher Sterility Assurance Experte in Projekten bezüglich Hygiene und Reinraum, Anlagen und Prozess-Design
  • Initiierung, Bearbeitung und Beurteilung von Änderungsanträgen für GMP gerechte Anpassung und Verbesserung von sicherheitsrelevanten Prozessen zur Sicherung von Sterilität
  • Erstellung von Präsentationen und Informationsdossiers im Rahmen von GMP-Inspektionen (vor der Zulassung und routinemäßig), internen Audits und Kundenaudits
  • Mithilfe bei der Beantwortung von Inspektionsbeobachtungen in Bezug auf die Sterilitätssicherungs-Konzepte
  • Training für die Mitarbeiter des Reinraumbereichs

 

Qualifikationen und Berufserfahrung:

 

  • Hochschulabschluss in Mikrobiologie/ Biologie/ Life Sciences/ Pharmazie oder vergleichbare Qualifikation.
  • Berufserfahrung in der pharmazeutischen Fertigungsindustrie
  • Erfahrung in der Qualitätssicherung und Einhaltung von GxP-, FDA-, EU- und anderen behördlichen Richtlinien sowie ISO Standards
  • Fundierte Kenntnisse in der Sterilitätssicherung für aseptischen Herstellung: aseptische Reinräume, aseptische Verhaltensweisen, Umgebungsmonitoring und Kontaminationskontrolle 
  • Sprachkenntnisse Deutsch und Englisch in Schrift und mündlich erforderlich
  • Kommunikations- und Teamfähigkeit
  • Kenntnis behördlicher cGMP und betriebliche Anforderungen
  • Verständnis produktionstechnischer Zusammenhänge und die Fähigkeit, diese in verständlicher Form schriftlich und mündlich dazulegen
  • Bereichsübergreifendes, strukturiertes und lösungsorientiertes Denken und Handeln

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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