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薬事品質保証部員
| Hiring Company | 宏輝株式会社 |
| Location | Tokyo - 23 Wards |
| Job Type | Contract |
| Salary | 6 million yen ~ Negotiable, based on experience |
Job Description
【求人No NJB2228173】
・薬事品質保証部の一員としてジェネリック医薬品の品質保証（GQP）から薬事申請に関わる業務全般をご担当頂きます。
・同社が輸入しているジェネリック薬品用の医薬品もしくは医薬品原料・中間体等、国内製薬メーカに関わる業務を担当頂きます。ご経験に合わせて、仕事をお任せします。
【具体的には】
・薬事申請：外国製造業者認定申請、適合性調査及び監査支援、業許可更新支援、医薬品原薬ＭＦ（マスターファイル）登録業務全般。
・海外の輸出会社との交渉（英語メール、電話）、品質保証：製造業者の製造管理から、変更管理、苦情処理、販売先メーカーの査察同行。
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
■必須条件 ・薬事申請又は品質保証の経験者。 ・医薬品業界経験者又は化学の知識がある方。 ・医薬品原料製造所の監査・査察経験のある方。 ■歓迎条件 ・外国語（英語又は中国語）可能な方Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Contract |
| Salary | 6 million yen ~ Negotiable, based on experience |
| Work Hours | 09:00 〜 17:30 |
| Holidays | 【有給休暇】初年度 10日 6か月目から 【休日】完全週休二日制 |
| Industry | Pharmaceutical |
Job Category
- Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
- Chemical, Food and Materials Technology > Production, Factory Manager, QC (Chemical, Food, Textile, Other Materials)
