日本の薬事規制に深く関わり、品質保証の専門性を高められる環境
企業情報
グローバルに展開するライフサイエンス関連企業で、革新的な医薬品や再生医療製品の品質保証を支える重要な役割を担います。国際的なプロジェクトに関わりながら、専門性を磨ける環境です。
職務内容
日本の薬事規制に基づくQA業務全般の管理
GMP監査の実施およびPMDA対応
海外クライアントへの規制情報の提供・説明(英語)
QA関連文書のレビュー、変更管理、CAPA対応
QMS、SOPの策定・維持管理
部門の目標設定、予算管理、メンバー育成
理想の人材
製薬業界でのQA業務経験10年以上
DMAH/MAHに関する品質保証業務の知識
GMP監査経験(PMDA対応経験歓迎)
What's On Offer
フレキシブルな勤務体系
グローバルプロジェクトへの参画機会
専門性を高める研修制度
キャリアアップを支援する評価制度
Contact: Kao Toyama
Quote job ref: JN
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Tokyo Michael Page· global{国}都 {王} qa{있소} mana{머래}{gc40} · 카세예 {ja} · 정로{qi}긄 {gmp} · oa{ie}kuru kikou ni tsuite no QA gyoumu kanri · ...
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Tokyo Michael Pageグローバルに展開するライフサイエンス関連企業で · 国際的なプロジェクトに関わりながら専門性を磨くことができます。 · 日本の薬事規制に基づくQA業務全般の管理 · GMP監査の実施およびPMDA対応 · ...
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Tokyo Michael Pageグローバル製薬業界のコンプライアンスにおけるQAリーダー国際的なステークホルダーと協働する機会企業情報日本で強い存在感を持つ世界的に認知された製薬企業倫理的医薬品、OTC、再生医療における革新に注力国際的な環境での協働を重視全業務においてコンプライアンスと品質の卓越性を追求キャリア成長とリーダーシップ開発の機会を提供科学的専門知識と規制知識を重視GMPおよびGQPの高水準維持に専念職務内容日本の規制当局(PMDA、MHLW)への申請用医薬品文書の作成倫理的医薬品、OTC、再生医療に関する日本の規制を正確に理解し適用規制およびコンプライアンス情報を海外クラ ...
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Tokyo Michael Page+グローバル製薬業界のコンプライアンスにおけるQAリーダー · + · +日本の規制当局(PMDA、MHLW)への申請用医薬品文書の作成 · 倫理的医薬品、OTC、再生医療に関する日本の規制を正確に理解し適用 · + · + ...
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