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Hiring Company | 日本新薬株式会社 |
Location | Kanagawa Prefecture |
Job Type | Permanent Full-time |
Salary | 5 million yen ~ 10 million yen |
【求人No NJB2119209】
■ 仕事の内容
小田原総合製剤工場・品質保証部における下記業務:
・将来の FDA 査察(核酸原薬の新規製造)に向けての準備(海外コンサルティング会社によるモック査察への対応、GMP 文書の英訳、英文説明資料の作成、査察対応マニュアルの作成、その他 FDA 査察に向けて必要な対応)
・核酸原薬の製造開始にあたっての品質保証面から必要な対応(原薬関連 SOP の整備等)
・その他品質保証に関する各種業務(変更管理、逸脱管理、教育訓練、SOP 作成、品質イベントシステムの導入など)
Minimum Experience Level | No experience |
Career Level | Mid Career |
Minimum English Level | Business Level |
Minimum Japanese Level | Native |
Minimum Education Level | Post Grad Degree (PHD/MBA etc) |
Visa Status | Permission to work in Japan required |
Job Type | Permanent Full-time |
Salary | 5 million yen ~ 10 million yen |
Work Hours | 08:30 ~ 17:00 |
Holidays | 【有給休暇】初年度 14日 1か月目から 【休日】完全週休二日制 土 日 祝日 年末年始 育児休業、介護休業 ※有給休暇は入社… |
Industry | Pharmaceutical |