- 製剤および包装の技術移転業務
- 商用包装形態の設計業務
- 包装表示の作成業務
- 生産におけるプロセス改善およびトラブル対応
- 各国当局への申請書作成業務
- 医薬品の製剤、包装の設計または工業化
- 包装表示(アートワーク)作成
- 医薬品製造のプロセス改善やトラブル対応
- 上記業務に付随する各国当局への申請業務
- 3年以上のGMP試験施設で医薬品製剤の試験経験を有する方。
- 医薬品、化粧品、食品業界の製造、包装に関する知識
- 医薬品のレギュレーションに関する知識
- 薬機法に基づく医薬品の表示に関する知識
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Manager or Specialist, Drug Product and Packaging Technology, Osaka Site - Takeda
説明
Description
Please note this job requires business level Japanese in speaking, writing, and reading.
タケダの紹介
タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。
タケダはグローバルな研究開発型のバイオ医薬品のリーディングカンパニーです。従業員は創業時から受け継いできたタケダの価値観であるタケダイズム(誠実=公正・正直・不屈)を道しるべとしながら、患者さんに寄り添い(Patient)人々と信頼関係を築き(Trust)社会的評価を向上させ(Reputation)持続可能な事業を発展させる(Business)を日々の行動指針としています。
"Better Health for People, Brighter Future for the World" is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We're looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company's founding. Takeda-ism incorporates and with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
募集部門の紹介
バーチャル工場として、日本及びアジアにおける医薬品製造委託先で製造される医薬品を管理・監督し、患者様へ提供する役割を担っています。その中でグローバルと連携し、製剤の製造や包装プロセスの確立、生産におけるトラブル対応や改善など、高品質な医薬品を常に提供できるように技術的な業務を担当しています。
職務内容
製剤および包装に関する技術、申請に関する知識、また包装表示に関する知識を基に、新製品の商用生産の立ち上げ、既存製品の技術移転業務、申請業務、生産のおける改善やトラブル対応および申請業務を実施する。
応募要件
医薬品の研究開発や製造(CMC関連業務)またはそれに類する研究開発や製造に関わった経験があれば望ましい。
学士以上
薬学系、理学系、農学系、化学系、機械系または工学系を専攻された方、もしくは同等の知識・経験・スキルを有する方。
以下の業務経験者、もしくはそれに相当する業務の経験者
英語で業務が遂行できるレベル(目安 TOEIC 730点以上)
製造委託先での業務となるために出張に対応できる方
待遇
諸手当:通勤交通費、借家補助費、勤務時間外手当など
昇給:原則年1回
賞与: 原則年2回
勤務時間:本社(大阪市中央区・東京都中央区)9:00~17:30 、工場(山口県光市・大阪市淀川区)8:00~16:45 、(千葉県成田市)8:45~17:15 、 研究所(神奈川県藤沢市)9:00~17:45
休日:土曜、日曜、祝日、メーデー、年末年始など(年間123日程度)
働き方関連制度:フレックスタイム制、テレワーク勤務制導入(対象社員)
休暇:年次有給休暇、特別有給休暇、傷病休暇、ファミリーサポート休暇、産前産後休暇、育児休暇、子の看護休暇、介護休暇
タケダの
Better Health, Brighter Future
What Takeda can offer you:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually
Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/Yamaguchi) 8:00-16:45, (Narita) 8:45-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Click to find out Takeda's Diversity, Equity & Inclusion
Better Health, Brighter Future
Locations
Osaka (Juso), JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time