Senior Specialist, Quality Assurance

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Job Summary / 業務概要

• Management and operation of GQP and GMP-related activities
  医薬品の品質管理業務（GQP）の管理と運営、及び医薬品品質システム（GMP）に関する業務全般
• Management and operation of QMS
  医療機器の品質管理監督システム（QMS）の管理と運営
• Handling GMP/QMS compliance inspections
  医薬品及び医療機器のGMP/QMS適合性調査の管理と対応
• Quality assurance of pharmaceuticals and medical devices
  医薬品及び医療機器の品質保証業務
• Self-inspections, internal audits, and external audits
  自己点検、内部監査、外部監査対応

Essential Duties & Responsibilities / 担当業務詳細

1. GQP & GMP Management / 医薬品のGQP・GMP管理

• Manage, operate, and maintain GQP
  医薬品の品質管理業務（GQP）の管理、運営、維持
• GMP oversight for domestic and overseas manufacturers
  国内外の製造業者のGMP対応
• Manage contract manufacturing organizations (CMOs)
  医薬品製造受託機関（CMO）の管理

2. QMS Management / 医療機器のQMS管理

• Manage, operate, and maintain QMS
  医療機器の品質管理監督システム（QMS）の管理、運営、維持

3. GMP/QMS Compliance Inspections / 適合性調査対応

• Application, coordination, and execution of inspections
  調査申請、行政窓口、問い合わせ、手配、実施対応

4. Quality Assurance Activities / 品質保証業務

• Quality assurance of assigned products
  担当製品の品質保証業務
  • Change control / 変更管理の対応
  • Non-conforming product management / 不適合製品の措置管理
  • Communication with manufacturing sites / 製造所とのコミュニケーション
  • Maintenance of Drug and Medical Device Files / 品質標準書・製品標準書の維持管理
  • Recall and hold handling / 回収・出荷停止対応及び記録管理
  • New product introduction support / 新製品導入対応
  • Other related tasks / その他関連業務

5. Audit Management / 監査対応

• Plan, arrange, monitor, and report self-inspections and internal audits
  自己点検・内部監査の計画、手配、監視、報告、管理
• Handle authority and corporate audits
  行政及びコーポレート監査の管理、対応、報告

Qualifications & Education / 必要な資格・学歴

• No specific qualifications required
  特段の資格は不要
• Preferred: University degree in medical/pharmaceutical fields and pharmacist license
  医学・薬学系の大学卒業、薬剤師免許保有が望ましい

Skills & Experience / 必要な知識・経験

• Mandatory: Minimum 5 years of pharmaceutical quality experience and CMO management
  必須: 医薬品の品質業務経験（5年以上）及びCMO管理経験

Technical Knowledge / 専門知識

GQP, GMP, QMS

• Knowledge of PMD Act, GQP/GMP/QMS ordinances, and related regulations
  薬機法、GQP省令、GMP省令、QMS省令、その他関連法規の知識・経験
• Experience managing CMOs
  CMOの管理経験
• Experience handling authority and overseas audits
  行政監査及び海外監査対応経験

GMP/QMS Compliance

• Experience managing inspections from application to completion
  GMP/QMS適合性調査の申請から完了までの対応経験

Quality Assurance

• Knowledge of pharmaceuticals and medical devices
  医薬品及び医療機器の知識
• Preferred: Experience in generic drug QA
  後発医薬品の品質保証経験があると尚良

Other Requirements / その他

• Willingness to take on new challenges
  未経験分野への挑戦意欲
• Positive mindset and teamwork
  物事を肯定的に捉える思考、協調性
• Analytical and negotiation skills
  分析力、交渉力
• English proficiency
  英語力

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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.

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