Manager/Staff, Quality Assurance, Osaka Site / 大阪工場 製品保証グループ 製品保証担当(課長代理/一般社員)

Reposted 3 Days Ago
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Osaka
Hybrid
Mid level
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Manage and oversee pharmaceutical quality assurance processes, ensuring compliance with GMP regulations, and continuously improve QA activities.
Summary Generated by Built In
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Job Description
This job requires native level Japanese proficiency in writing, reading and speaking.
【タケダの紹介】
タケダでは、常に患者さんを中心に考え、その生活を豊かにするためにイノベーションを推進しています.そして、従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも取り組んでいます.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.
タケダは約5万人の従業員が、80以上の国や地域で働くグローバルな企業です.すべての従業員が世界中の人々の生活をより良いものにしたいという信念をもち、そしてタケダイズム(誠実:公正・正直・不屈)を日々の業務で体現しています.私たちは、240年以上の研究開発型の製薬企業としての伝統のもと団結し、優れた医薬品の創出を通じて、人々の健康と医療の未来に貢献することをミッションとして掲げています.
【募集部門の紹介】
大阪製薬品質部 製品保証グループでは、大阪工場における医薬品(注射剤)の製造および試験検査を管理・監督し、製造された医薬品の品質が確かなものであることを保証し、患者様に提供する役割を担っています.
【職務内容】
医薬品(無菌注射剤)の品質保証(GMP)業務
製造部門・試験部門で発生した逸脱処理を行い、製品品質を保証する業務を行っていただきます.また、製造エリア・試験エリアの巡視、製造記録のレビュー、製造機器・試験機器のアドミニストレーター業務、使用決定・出荷判定準備業務並びに担当業務の継続的改善活動も必要に応じて行っていただきます.
これらの業務を通じて品質保証業務に関するスキルと専門性を高めていただきます.
【応募要件】
《学歴》
薬学、理学、工学、農学系の学位取得者
《必須:実務経験・スキル》
・医薬品の品質管理、製造に関するGMP業務の経験および知識を有する方
《望ましい:実務経験・スキル》
・医薬品の品質保証に関する実務経験を有する方
・無菌医薬品の知識があればより望ましい
《語学》
・英語によるメールや資料の読み/書きができること、英語によるコミュニケーション力向上に継続的に取り組んでいただけること
《勤務》
勤務時間:完全フレックス(コアタイムなし)
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
Osaka (Juso), Japan
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Top Skills

Gmp

What the Team is Saying

Lavanya Wadhwa
Christina Alves
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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. 

We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.  

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.  

Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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Employees engage in a combination of remote and on-site work.

Takeda's hybrid policy varies by role. Be sure to ask your recruiter about the requirements for the role that you are applying for.

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