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Launch＆Change Management担当 / スタッフ～管理職
| Hiring Company | ベーリンガーインゲルハイム製薬株式会社 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 5 million yen ~ 10 million yen |
Job Description
【求人No NJB2259846】
1. CMOにて発生する各種変更（原薬・副原料・機器等）に対して、CMOからのQualification計画を製剤技術の観点からReviewし、実行する。
（工業化検討・PQ/PV計画書/報告書Review 必要に応じて現場立会い） 同様にCMOと協議し、Process堅牢化・改善を進める。
2. 新製品の中で、ドイツからの完成品輸入品、国内CMO包装品について、立上げ準備を行う。
技術的な立場から日本国内での新製品立ち上げProjectに参画し、ドイツ・国内CMOと協力しながら準備を進める。
3. CMOにて発生する各種変更に伴う、承認書への記載内容変更案のReview
新製品の薬事申請書類のReview
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Fluent |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
※下記はスタッフ採用での必須条件
〇Required Education
・Bachelor degree of above
・Background in pharmaceutical science engineering production management material management or the equivalent in experience
〇Required Skills
・Extensive knowledge and experience in manufacturing/packaging equipment processes of pharmaceutical products.
・Well understanding of regulations （GMP Japanese regulations etc.）
・Experience in CMC documentation
・Communication skill and strong negotiation skill
〇Language
English：Business Level
Japanese：Native or Business Level
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 5 million yen ~ 10 million yen |
| Work Hours | 08:45 ～ 17:20 |
| Holidays | 【有給休暇】初年度4～16日付与（入社月により異なります） ＊入社時より使用可 【休日】完全週休二日制 年末年始 創立記念日、… |
| Industry | Pharmaceutical |
Job Category
- Machinery and Automobile Technology > Project Manager (Machinery, Automobile)
- Chemical, Food and Materials Technology > Production, Factory Manager, QC (Chemical, Food, Textile, Other Materials)
Company Details
| Company Type | International Company |
