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Manager or Specialist, Quality Assurance for Investigational Medicinal Products / 治験薬品質保証 課長代理または担当者

Fujisawa, Kanagawa
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0111664 Date posted 12/06/2023 Location Fujisawa, Kanagawa

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Job Description









  • 開発プロジェクトのGMP遵守状況の監視

  • 製造方法・試験方法の承認

  • 治験薬出荷(製造記録照査を含む)

  • 治験薬製造における変更管理

  • 治験薬製造における逸脱・OOS/OOT・苦情の調査

  • サプライヤーに対するGMP監査ならびに品質契約の締結

  • 継続的な品質システムの改善






  • 原薬または製剤に関する品質保証もしくは品質管理業務

  • 原薬または製剤の製造法もしくは試験法開発業務

  • 原薬または製剤の製造もしくは試験業務


  • 医薬品の製造または試験に関する知識

  • 医薬品製造における最新のGMP要件とガイダンスに関する知識

  • 問題を予測し、解決策を積極的に提案・実行する能力

  • 複雑な問題を正しく理解し、顕在化しているまたは潜在的なリスクを特定・解消する能力

  • 困難に際して利害関係者と交渉し、相互に有益な解決策に到達する能力




JPN - Kanagawa - iPark

Fujisawa, Japan

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Full time
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Fujisawa, Kanagawa

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