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Spec, Medical Device Safety

Req # JR - 144554 Location Minato, Tokyo, Japan Job Category Quality Date posted 08/30/2024
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Spec, Medical Device Safety

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Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Role Overview 職務概要

医療機器の製造販売後安全管理の基準に関する省令（GVP省令）に基づき、製造販売業の許可要件であるGVPの構築、運営、維持に貢献する。

Key Responsibilities主な職務内容

■担当しているプロセス

1．安全管理情報（医療関係者からの情報、外国規制当局、文献、製造元、関連企業、行政等）の収集、受理、精査・評価、安全確保措置の立案（不具合報告書、外国措置報告書等の作成）と、安全管理責任者の承認・指示の下、立案した措置の実施（不具合報告書、外国措置報告書等の提出や、安全管理文書の配布に係る業務等）、特に行政（PMDA）報告業務。

2．添付文書作成及び改訂業務（安全性関連項目へのコンテンツ）

3．教育訓練、自己点検、手順書の整備

4．GVP業務の委受託管理業務（契約関係の素案作成）

5．定期報告（未知非重篤症例、生物由来製品感染症定期報告）に係る業務

■成果物、ターゲット

行政(PMDA)提出用報告書（不具合報告書、外国措置報告書）、SOPで定められた書式による記録（不具合管理票等収集した情報の評価票、教育訓練記録）、委受託管理記録（業務記録、手順書、業務記録）。これらの成果物を、法定期限内かつグループ内目標期限内に完成させる。

Qualifications求められる経験・スキル・知識

■社会人として一般的な技能

1．担当する業務を、責任感を持ち期限までに完了させる。

2．良好なコミュニケーションスキルを持ち、顧客（社内関連部署、行政を含む社外）を意識した行動がとれる。好感を与える態度をとり、信頼関係を構築できる。

3.  適切なタイミングで報告、情報提供を、上長や関係者に行うことができる。

4．論理的に考え、理論構築し、説明することができる。

5．簡潔で分かりやすく、誤解を招かない、日本語の作文能力。

6．ワード、エクセル、パワーポイント、Eメール等のPCアプリケーションの基本スキル。

7．中程度の英語力（読解と基本的な英文作成能力）。

■業界として必要な専門知識

1．医療機器GVPを含む法体系についての理解。薬機法、GVP、QMS等の関連法規を理解し、実務と結びつけることができる。

2．担当する医療機器についての理解（製品仕様に加え、原理、製造工程の基礎知識）と、その機器を用いた臨床についての理解（臨床での使用環境や適応疾患）。

3．添付文書の役割とその要求事項に対する理解及びその周辺知識（医療機器リスクマネジメントにつての基礎知識）

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

144554
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Address

Explore this location 30F Granpark Tower, 3-4-1 Shibaura
Minato-ku, Tokyo
108-0023
Japan Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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