募集要項
- 仕事内容
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Work with Quality Systems such as Document Control
Work within Global eQMS and eDMS/eTMS systems
Provide support for internal, external (Regulatory/Notified body) and supplier audits
Provide support for activities such as Supplier Management, electronic signature etc.
Actively participate as a member of the QA team on site, in partnership with both the Site Head and Global QA Sr. Director
Participate in local project implementations, and/or be part of larger project teams
Act as subject matter expert/intermediary in communications between Regulatory/Notified bodies and overseas manufacturing sites
Work with the Warehouse/3PL team on a daily basis to ensure smooth running of activities (including product release and re-labelling)
- 応募資格
-
- 必須
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必須条件
2年以上IVDもしくは医療機器業界経験(医薬品経験者もお気軽にお問い合わせください)
QA、QMSもしくはGMP知識
流暢な英語力(会話を含む)
- 歓迎
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歓迎される資格・経験
薬剤師資格
- 雇用形態
- 正社員
- ポジション・役割
- QAまたはQMS Function
- 勤務地
- 東京都
- 年収・給与
- 基本給680万円+別途賞与など