Tokyo Michael Page
医薬品製造における品質の卓越性を推進
患者の安全を確保するグローバルチームの一員になる

企業情報

日本で強い存在感を持つグローバルなヘルスケアソリューションのリーダー

革新と患者安全へのコミットメント

クロスファンクショナルなチームとの協働的な職場環境

プロフェッショナルな成長と国際的な経験の機会

コンプライアンスと品質の卓越性に強く注力

サステナビリティと倫理的なビジネス慣行に専念

医療分野で有意義な影響を与えるために従業員を支援

職務内容

CMOの主要な品質窓口として対応

製造および製品出荷に関するGxPおよび社内基準への適合を確保

バッチ記録、バリデーション報告書、変更管理などのcGMP文書をレビュー・承認

逸脱調査を主導し、是正措置を実施

KPIに対する委託業者のパフォーマンスを監視し、悪化傾向をエスカレーション

承認された仕様に基づく製品出荷を監督

CMOとの内部および合同会議に参加し、品質目標を調整

CMOの運営管理を支援し、プロジェクト管理活動に貢献

社内品質システム、文書を維持し、監査や自己点検に参加

サイト品質レビューや予算管理に関するインプットを提供

理想の人材

薬学または化学の学位

バイオ医薬品製造またはQA/QCでの最低5年の経験

GMP/GQP/GDPおよびバリデーションプロセスの深い理解

無菌製造およびCMC規制要件の経験が望ましい

日本の申請書レビューおよび当局とのコミュニケーションに精通

日本語ネイティブでビジネスレベルの英語力

優れた注意力、コミュニケーション能力、交渉スキル

柔軟で新しい挑戦を積極的に受け入れる姿勢

What's On Offer

競争力のある給与と福利厚生

グローバルなヘルスケア企業で働く機会

専門的な成長とキャリアアップ

協力的で包括的な職場文化

患者の安全と製品品質に直接影響を与える役割

Contact: Zach Itozu

Quote job ref: JN
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