Chiyoda MSD フルタイム

Job Description

このポジションは、薬機法に基づく総括製造販売責任者、およびGQP省令に基づく品質保証責任者としての責務を担います。また、当社のリーダーシップチームにおいては品質保証の責任者となり、医薬品の安全管理責任者と協力しながら製品の安全性に関する推奨事項の作成などを通じて継続的にコンプライアンスを確保します。 照合したバッチ記録と日本で実施した QC テストデータに基き、日本への輸入製品および日本での製造委託業者から供給される製品の品質を継続的にモニターし、確実な出荷につながるよう管理責任を持ちます。 安全性と品質に関する案件や突発事項などについて、関係省庁に適時報告します。

  • アニマルヘルスの外部製造品質担当エグゼクティブディレクターの直属であり、グローバル外部製造品質チームのメンバーとなります。グローバルからの指導や指示を受けながら独立して責任を持ち、業務を遂行します。当該業務の進捗状況、改善機会、問題等について上司に報告します。
  • 当社の総括製造販売責任者、及び品質保証責任者を務める。社内のリーダーシップ チームの一員としての責務を持ちます。
  • ・QA組織、チームを管理します。
  • ワクチンの国家検定について、定められた検査所と調整し、日本向けに輸入されたワクチンおよび医薬品のリリースに関する QC 検査およびバッチレビューを行う。
  • 日本の製品登録書類および製造許可に適合する製品を受け取るため、日本とグローバルの薬事部門、および日本へ製品を輸出する製造拠点との調整・協力を行います
  • 日本に製品を輸出する製造拠点との間で TQAが整備され、維持されていることを確認します。
  • グローバルのアニマルヘルスクオリティマニュアルおよび日本のクオリティマニュアルが日本の現行規制要件を反映し、グローバルおよび日本のコンプライアンスをサポートしていることを確認。
  • 社内および規制当局の監査(グローバル品質保証、HA、顧客)の主催を担当。
  • クロスファンクショナルな調査やプロジェクトチームに効果的に貢献。
  • 社内のR&Dや薬事申請書類の監査。

資格、スキル、経験

  • 薬学の学士号、薬剤師免許。
  • 日本語ネイティブレベル、英語力要(読み書き、スピーキング)
  • GMPおよび薬事要件に関する豊富な知識経験、品質システム、品質保証、および品質管理に関する専門知識と幅広い経験
  • サイエンスやデータ、および進化する環境における規制要件の理解に基づいた、優れた問題解決スキル、リスク管理対応力
  • 薬学、分析化学、微生物学、無菌操作、cGMP、薬事などの専門知識
  • ワクチンの製造および検査経験
  • 多様な文化において人間関係構築、コミュニケーション、交渉力、説得力、リーダーシップスキルを示す能力、組織の複雑さや曖昧さに対処できる能力
  • チームをリードし、動機付けなど、模範的な人材/チームのリーダーシップ経験
  • パフォーマンス指標を確立し、結果に責任を持たせた経験
  • ワクチンQC における経験と問題解決スキル。

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:12/31/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R281796



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