Date posted:
Jan 29, 2026
City:
Tokyo
Country/Region:
JP
Type of Contract:
Full-time Employment / Unlimited
Job Requisition ID: 10462
Quality Assurance Technical Service Specialist
業務内容:
製造委託先との製品に関する連携、技術移管及び移管後の維持管理を含む
医薬品開発プロジェクト・変更管理の進捗管理
国内外の委託先調査および連絡窓口
海外技術部門とのCMC業務に関する連携窓口
新規・定期のGMP適合性調査の調整
MF及びFMA等の外部委託先との交渉・連携
■採用背景:
弊社が製造販売している4製品に関して、変更管理プロジェクトが複数稼働しています。その中で、GQP関連業
務を技術面及び規制面から推進できる人材を探しています。
■組織について:
弊社品質保証部は、Document Control, Customer Service, Product Control, Technical Service
の4チームから構成されます。今回の募集は、主に技術者、製造所、外部委託先と綿密に連携するポジションとな
ります。
■職務の魅力:
「物作り」の観点から、医薬品の安定供給に携われます。日本独自のGMP関連の薬制業務を理解できます。
■得られる経験:
GQP・GMPの品質保証システムを俯瞰しながら、多くの関連部署、関連会社と業務に携わることができます。
■必須要件/Required:
CMC関連業務で製造委託/受託の経験があり、ガントチャートの作成・管理ができる。
医薬品製造業と製造販売業でCMC管理もしくはCMC薬事、品質保証としての業務経験(3年以上を
歓迎)
日本語および英語でのコミュニケーション能力を有すること。
英語:
ビジネスレベル
■歓迎条件/Preferred:
GMP適合性調査の提出資料作成・照会対応の経験のある方
医薬品製造現場(QA、QC、技術/バリデーション、製造など)での製造管理及び品質管理の経験(3年以上)
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients.
You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself.
Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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