By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.
I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description:
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 the 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 Integrity, Fairness, Honesty, and Perseverance, 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:
タケダにて治験薬の開発と製造を担う部門であるPharmaceutical Sciencesは治験薬の供給能力の強化を目的として湘南アイパークに無菌医薬品製造設備を建設しております。
治験薬の品質保証を担う私たちPharmaceutical Sciences & Device Qualityは新規設備の導入ならびに竣工後に実施される治験薬製造が最新のGMPに合致していることを保証します。
最新設備の導入に始まり、設備の稼働後には低分子薬・抗体医薬・核酸医薬といった様々なモダリティの治験薬製造の品質保証業務に携わりますので、タケダのダイナミズムを感じることのできる部門です。
職務内容:
以下の品質保証業務を担当頂きます。
無菌医薬品製造設備のクオリフィケーション/バリデーション図書の照査
出荷判定(製造記録照査を含む)
製造活動の現場監視ならびに自己点検の実施
製造に関する変更の照査
製造に関する逸脱、OOS/OOTまたは苦情の調査結果の照査
原材料の供給業者に対するGMP監査の実施ならびに供給業者との品質契約の締結
内部監査ならびに顧客監査の対応
継続的な品質システムの改善の推進
応募要件:
<学歴>
大卒以上で、薬学、化学、生物学、工学、または関連する科学分野の学士号を有する方。上級学位(MS、PhD、PharmD)を取得しているとなお好ましい。
<実務経験>
製薬またはバイオテクノロジー業界で8年以上の経験があること
品質保証、品質管理、コンプライアンス、または製造のいずれかの分野で責任を担ってきた経験
部門横断業務で実績のある方
グローバル開発プログラムのサポートおよび規制当局とのやり取りの経験があれば尚可
品質監査資格、または同等のGxP監査経験があれば尚可
<スキル・資格>
無菌医薬品の製造プロセスならびに製造設備に関する知識
無菌医薬品製造に関するGMP要件とガイダンスに関する知識
優れた品質リスク評価および意思決定能力
優れたコミュニケーション能力と部門横断的な連携能力
細部への高い注意力とコンプライアンス意識
グローバルな環境において複数の優先事項を管理できる能力
問題解決能力と継続的な改善推進能力
<語学>
英語:
口頭及びメールで業務上のコミュニケーションができるレベル(ビジネスレベル)
<その他>
ハイブリッド・ワーキング・モデルを導入しております。製造活動中はオフィスでの勤務が必須となりますが、製造が行われていない時には在宅勤務も可能です
供給業者へのGMP監査などのために年に複数回の国内出張が見込まれます
求める人物像:
関係者からの信頼を築き、責任感を持って業務に臨める方
メンタリングとサポートを通じて自己の能力を構築できる方
情報に基づいたタイムリーな意思決定を行える方
チームや文化を超えて効果的に連携できる方
イノベーションと優れた品質を推進できる方
Takeda Compensation and Benefits Summary:
Allowances Commutation, Housing, Overtime Work etc.
Salary Increase Annually, Bonus Payment Twice a year
Working Hours Headquarters (Osaka/ Tokyo , Production Sites (Osaka/ Yamaguchi , (Narita , Research Site (Kanagawa
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, TeleworkBenefits Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the company's discretion.
It is possible the department and workplace may change at the company's discretion.
Locations:
JPN - Kanagawa - Fujisawa
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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