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Qualified Person (w/m/d)

Singen (Hohentwiel), Germany


Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Qualified Person (w/m/d)

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Job ID R0010139 Date posted 07/03/2019 Location Singen (Hohentwiel), Germany

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Job Description

This job requires proficiency in German.

Ihre Aufgaben

  • Sicherstellung der GMP- und zulassungskonformen Herstellung und Prüfung von Arzneimitteln
  • Verantwortlich für die Bearbeitung, Evaluierung und Bewertung von Abweichungen und Reklamationen
  • Nachverfolgung von CAPA-Maßnahmen bei Beanstandungen und Abweichungen
  • Verantwortlich für die Durchführung des Batch Record Reviews
  • Zuständig für Chargenzertifizierung
  • Verantwortlich für das Betäubungsmittelmanagement-System
  • Führung von Audits während BOPST-Inspektionen und halbjährige Berichterstattung

Ihr Profil

  • Approbation als Sachkundige Person gemäß § 14 AMG (Qualified Person)
  • Mindestens 5 Jahre Berufserfahrung im GMP-Umfeld der Pharma- oder Biotechnologie
  • Analytisches Denkvermögen und Verständnis für komplexe Fragestellungen
  • Technisches Fachwissen zu Produktherstellungsprozessen und sehr ausgeprägtes Wissen in QMS (z.B. Abweichungen, Change Control und CAPA-Management)
  • Fließende Deutsch- und Englischkenntnisse in Wort und Schrift
  • Ein hohes Maß an Eigeninitiative, Teamfähigkeit und Flexibilität


Singen, Germany

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0010139

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