<職務内容> 品質管理グループでは、原材料、経口製剤、注射剤、バイオ医薬品などの品質試験および品質試験を実施するためのサポート業務(サンプル管理、QCリリース、試験調査)を行っています。また、社内の関係部署と連携を取りながら、製品の安定供給に貢献しています。 具体的には以下の業務を行います。 名古屋工場で実施する品質試験(受入試験、出荷試験、安定性試験) 名古屋工場で実施する品質試験(受入試験、出荷試験、安定性試験)のスケジュール管理およびサンプル管理 名古屋工場で実施する品質試験に係るQCリリース業務 名古屋工場に入荷する包装資材に係る受入試験業務 名古屋工場で実施する包装外観検査 品質試験に係るトラブル(工程異常、試験結果不適)への対応 LIMS(laboratory Information Management System)及びラボ関連システムを使用したデータ管理 最新のGMP及びData Integrity要件を理解した上でQC業務遂行 IMEx体制における継続的な業務カイゼン <必須経験・資格> ・薬学など理系の大学又は大学院程度の知識があること ・分析機器(HPLC、GC、UV、IRなど)を使用した医薬品の分析、もしくは、そのデータのレビューなどの経験が直近で3年以上 ・GMPや日本薬局方、品質に関するガイドラインについての知識があること ・組織の一員として部門メンバーと協力して業務を行える協調性があること ・業務を行う上で必要最低限の英語力があること(TOEIC 500点程度) <勤務地> ファイザー・ファーマ株式会社 名古屋工場 <募集人員> 2名 Work Location Assignment: On Premise Pfizer is an
At BBH we value diverse backgrounds, so if your experience looks a little different from what weve outlined and you think you can bring value to the role, we will still welcome your application! What You
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