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| Hiring Company | 大手外資製薬メーカー |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 14 million yen |
【求人No NJB2354974】
主な業務は、日本における品質管理システム(QMS)の管理・維持、規制当局によるGVP/GPSP検査や内部外部監査の調整・対応、是正処置(CAPA)の主導です。グローバルのコンプライアンス・品質・教育チームと連携し、GVP/GPSP要件を満たすためのコンプライアンス戦略やプロセス改善を推進します。チームメンバーの育成や誠実さ・品質・遵守の文化醸成も担います。
| 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 |
Qualifications
Degree Requirements
University Bachelor of Science or Master of Science desirable.
Pharmacist license desirable.
Required experience
Five (5) years pharmaceutical industry and GVP or GPSP operational experience.
Required knowledge
Knowledge of Pharmaceutical Medical Device Act. Fair Competition Code (FCC) Promotion Code and related regulations GVP/GPSP ministerial order.
Knowledge on provision of Medical Information in Japanese industry.
Basic knowledge on safety management for pharmaceuticals.
Key Competency Requirements
Negotiation skill on issues with internal and external stakeholders
Communication skills in Japanese
English reading and writing skills
Cross functional collaboration skill
Presentation skill
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 14 million yen |
| Work Hours | 09:00 ~ 17:15 |
| Holidays | 【有給休暇】初年度:試用期間終了後1~10日(入社時期により異なる)/2年度目:13日 ※入社後、年間休日日数は年毎に変更がご… |
| Industry | Pharmaceutical |
| Company Type | International Company |