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Manager or Specialist Quality Assurance / 品質保証担当

Hikari, Japan


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 2021.

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

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Manager or Specialist Quality Assurance / 品質保証担当

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Job ID R0017072 Date posted 02/18/2020 Location Hikari, Japan

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Job Description

This job requires native level Japanese proficiency in writing, reading and speaking.




GMS Japan 光工場は山口県光市にあるタケダの主力生産工場で、光工場はグローバルの供給ネットワークの中でも重要な基幹工場としての役割を果たしており、出荷先は国内に限らずグローバルに製品を供給しています。








・出荷判定 など







  • 原薬または製剤に関する品質保証・管理業務
  • 原薬または製剤に関する技術・エンジニア関連業務
  • 原薬または製剤に関する薬事関連業務
  • 原薬または製剤の製造業務


  • 医薬品の製造等に関する知識
  • 薬規法、GQP、GMPなどの規制に関する知識
  • 上記に加えて、以下の知識を有している方が望ましいが、未習熟であっても構わない。
  • データインテグリティに関する知識

  • (日本に限らず)薬事対応・医薬品申請許認可に関する知識

  • 海外当局査察対応の知識


  • 英語力:ビジネスレベル(TOEIC 730点以上、あるいはそれに相当する程度の英語能力)



昇給・賞与: 昇給 原則年1回 賞与 年2回

勤務時間: 本社(大阪・東京) 9:00~17:30/工場(大阪・山口) 8:00~16:45 /研究所(神奈川)9:00~17:45


休暇: 年次有給休暇、特別有給休暇、リフレッシュ休暇、産前産後休暇、育児休暇、子の看護休暇、介護休暇、フィランソロピー休職制度



Hikari, Japan

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0017072
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