日本市場における品質戦略の中核を担う責任ある役割
企業情報
世界中で医薬品の研究・製造・供給を行うグローバル企業。革新的な医療ソリューションを提供し、患者様の生活の質向上に貢献しています。日本市場でも長年の実績があり、品質・安全性に対する高い基準を持つ企業です。
職務内容
日本国内のCMOに対するGxP監督責任
GMPおよびGQPに基づく外部製造業者の管理
日本薬事法、薬局方、社内品質指針に基づくコンプライアンスの確保
CMCコンプライアンスの維持と当局対応
品質契約の管理と社内外関係者との連携
品質改善の機会の特定と実行
グローバル品質プログラムの導入と維持
チームの育成・指導・組織構築
KPIの設定と報告、リスクマネジメントの実施
デジタルツールを活用した業務改善
理想の人材
薬剤師資格または理系修士・博士号
製薬業界での15年以上の経験(うち品質関連業務3年以上)
製造現場でのQA/QC経験
条件・待遇
グローバルな環境でのキャリア構築
社内外との連携による幅広い経験
デジタルツールを活用した業務効率化
社員育成に注力する企業文化
安定した雇用と充実した福利厚生
Contact: Kao Toyama
Quote job ref: JN
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Tokyo Michael Page ¥5,000,000 - ¥10,000,000 per yearグローバル製薬企業の品質保証部門をリードする責任ある役割です。日本市場における品質戦略の中核を担います。 · 日本国内のCMOに対するGxP監督責任 · GMPおよびGQPに基づく外部製造業者の管理 · 日本薬事法、薬局方、社内品質指針に基づくコンプライアンスの確保 · CMCコンプライアンスの維持と当局対応 · 品質契約の管理と社内外関係者との連携 · 品質改善の機会の特定と実行 · グローバル品質プログラムの導入と維持 · チームの育成・指導・組織構築 · KPIの設定と報告、リスクマネジメントの実施 · デジタルツールを活用した業務改善 · ...
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