医薬品の品質保証強化体制

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Job details

Company overview

We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.

Responsibilities

• 薬事省令対応（GQP、GMP、QMS） 
• FDA査察対応 
• GMP適合性調査申請 
• 原薬／医薬品製造所のGMP／QMS適合状況、品質保証体制確認、  指導のための実地監査の実施 
• 国内外上市医薬品製品等の初期流動品質の確認・監査

Requirements

必須経験： 

• 製造所におけるQMS/GMPの実務経験  
• 薬事業務経験者 
• FDA査察等の行政査察の経験 
• ビジネスレベルの英語力（コミュニケーション）

Salary

6 - 10 million yen

Location

Tokyo