職務の目的および主な業務内容 Quality Management Systemの中で、主に以下の業務を担う。 ・品質の取り決め書(原料、主原料、製品のサプライヤーとの品質契約書 及び製販との取り決め書含む)の作成 ・製品及び原料の品質QC実験用の規格基準設定、規格設定におけるJustification Reportの作成 ・製品に使用される資材の規格設定及び取り決め書(品質契約書)作成 ・変更管理(サイト内で提起された変更管理・サプライヤー・海外サイトによる変更内容の管理) ・サプライヤーコントロール(資材・原料・製品・サービスプロバイダー等工場全体で使用するサプライヤーの評価及びコントロール) 上記の業務を実施しながら、生産現場を含むQA以外の部、Functionとも連携をとり、改善活動を実施していく。 上記業務のほかに コンプライアンス課では、文書管理、教育管理、自己点検、ワクチンの国家検定、当局対応などを主とするGroupがあり、2つのGroupにてお互い協力しながら、業務を遂行している。よって、QMSの多岐にわたる業務にかかわることができ、将来のQA内外へのキャリアプランやDevelopmentにプラスとなる業務を担うことができる。業務の内容によっては、グローバルチームや他のサイトとのCommunicationをとることがある。 必要な条件 スキル ・GMPの知識 QMS概論の知識 ・局法(JP, USP, EP)の知識 ・英語(技術文書の読解、メールでのコミュニケーション、電話会議参加) ・PC skill(Word, Excel, PowerPoint) ・基礎的な問題解決能力 ・工場内外において相互協力、協調して作業を行う能力(コミュニケーション能力) 経験 ・製造業での品質業務経験 ・当局監査対応 学位/資格/語学力 ・薬学、化学、工学等の理系分野の学士以上 望ましい条件 スキル ・医薬品の生産工程、関連する原資材に関する必要とされる知識
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