Manager or Specialist, Quality Assurance, Investigational Medicinal Products Pipeline Development, Shonan iPark / 湘南アイパーク 治験薬品質保証‐開発担当 課長代理または担当者

Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited

Quality Assurance
Kanagawa Prefecture, Japan
Posted on Dec 13, 2024

Manager or Specialist, Quality Assurance, Investigational Medicinal Products Pipeline Development, Shonan iPark / 湘南アイパーク 治験薬品質保証‐開発担当 課長代理または担当者

Fujisawa, Kanagawa

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 R0137938 Date posted 11/13/2024 Location Fujisawa, Kanagawa

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Please note this job requires business level Japanese in speaking, writing, and reading.

タケダの紹介

タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。

タケダはグローバルな研究開発型のバイオ医薬品のリーディングカンパニーです。従業員は創業時から受け継いできたタケダの価値観であるタケダイズム(誠実=公正・正直・不屈)を道しるべとしながら、患者さんに寄り添い(Patient)人々と信頼関係を築き(Trust)社会的評価を向上させ(Reputation)持続可能な事業を発展させる(Business)を日々の行動指針としています。

”Better Health for People, Brighter Future for the World” is the purpose of the company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

募集部門の紹介

治験薬品質保証は臨床試験に用いる治験薬の開発における品質保証を担当する部門です。開発される治験薬は合成低分子・ペプチド・抗体・オリゴヌクレオチドなどの様々なモダリティに富んでいます。

製造・試験・薬事部門からのメンバーで構成される医薬品開発チームに参画し、治験薬の開発ならびに製造がGMP要件に準拠して計画・実施されていることを治験薬品質保証は確認・監督しています。

また、グローバルチームと連携し、最新の各国GMP要件に適合した品質システムへと改善する業務にも従事しています。

職務内容

以下の品質保証業務を担当頂きます。

  • 開発プログラムの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

応募要件

<学歴>

大卒以上で、薬学、工学、理学、農学系などの分野を専攻された方、もしくは、同等の知識・経験・スキルを有する方

<実務経験>

下記業務のいずれかについて2年以上の経験がある方

  • 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

<専門性:必要な知識>

  • 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

<語学>

ビジネスレベル:口頭及びメールで円滑にコミュニケーションできるレベル

求める人物像

  • 患者さんの健康、幸福および安全を第一に考えることのできる方
  • 法令・手順を遵守して業務を遂行できる方
  • 多様性を認め、自分とは異なるメンバーを尊重して協働できる方

Takeda Compensation and Benefits Summary:

  • Allowances: Commutation, Housing, Overtime Work etc.

  • Salary Increase: Annually, Bonus Payment: Twice a year

  • Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

  • Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

  • Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

  • Flexible Work Styles: Flextime, Telework

  • Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

  • It is possible the job scope may change at the company’s discretion.

  • It is possible the department and workplace may change at the company’s discretion.

Locations

Fujisawa, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Working at Takeda

  • Inclusion

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

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

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

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

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

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

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Related Content

About our location

Fujisawa, Kanagawa


View Map of Fujisawa, Kanagawa

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