【郡山工場:品質保証】Advanced Quality Assurance Professional Job at ノボ ノルディスク ファーマ(株), 福島県

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  • ノボ ノルディスク ファーマ(株)
  • 福島県

Job Description

品質保証アドバンスドプロフェッショナルとして、以下の業務を行っていただきます。
■郡山工場における品質保証プロセスの監督

■施設やユーティリティの規制要件への準拠を維持し、監査や検査をサポートし、基準の遵守を確認する
■グローバルプロジェクトメンバーと協力し、他地域のベストプラクティスを取り入れながら、品質保証プロセスを強化する戦略を立案・実行する
■患者や製品に対する潜在的なリスクを特定するためのリスク評価など、品質を評価するための定量的な測定や手法を確立する 【必須】
■医薬品の製造拠点(GMP)における品質保証のご経験
■グローバルとのコミュニケーション可能な英語力

(⇒業務続き)
■原材料から最終製品に至るまで、エンド・ツー・エンドの品質保証を監督し、日本およびグローバルの規制基準への準拠を確保する

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