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VBU治験薬GMP品質保証ヘッド

Hikari, Japan

Overview

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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Success

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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Opportunity

  • 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 2020.

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

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VBU治験薬GMP品質保証ヘッド

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Job ID R0020442 Date posted 07/17/2020 Location Hikari, Japan

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Job Description

1. Quality Assurance

  • Executed batch records are reviewed and approved to ensure they meet current GMPs and internal procedures.
  • Quality events (deviations, OOS/OOT and non-conformances) are investigated to identify root cause(s) and impacted materials and to establish effective CAPAs.
  • Operations associated with production, validation activities, line clearance, cleaning and GMP environment receive appropriate oversight.
  • Validation/qualification documents including VMP for process, methods, cleaning, equipment, computer and supporting systems are reviewed and approved.
  • Final release/reject decision for raw materials, intermediates and finished products.

2. Quality Systems

  • Change requests are assessed and correct implementation of the changes is ensured.
  • Site documents such as Standards, SOPs/Instructions, MBRs and Product Master Files are developed, reviewed, approved and managed.
  • GMP training programs are established and maintained and GMP training sessions are planned to ensure adequately training.

3. Quality Compliance

  • Metrics for quality, operations, and product performance are trended.
  • Customer complaints are investigated and appropriate CAPA are ensured.
  • Regulatory inspections and customer audits are coordinated and organized.
  • Site Quality Council Meetings are planned and hosted for management review.

4. Quality improvement projects are identified, aligned with global VBU quality and objectives, planned, and tracked to timely completion

5. Strategic projects, such as Quality Culture, are aligned with Global VBU quality expectations and timelines and receive appropriate priority

6. Foster and qualify talents in IMP GMP QA (VBU) with their career plan for sustainable growth of the organization.

7. Prepare IMP GMP QA (VBU) cost budget and oversee execution against plan/budget

Locations

Hikari, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0020442

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