Make your mark for patients 患者さんのためにあなたの力を発揮してください 概要 埼玉工場で製造し、日本市場へ出荷する医薬品の品質を保証するポジションです。国内規制、医薬品業界のガイドライン、社内品質基準に基づき、品質システムの構築・維持・改善を担います。部下を持たない専門職（Individual Contributor）としてプロジェクトや品質改善をリードいただくポジションです。 主な業務内容 1. 品質保証（Quality Assurance） ・日本市場へ高品質な製品を安定的かつ継続的に供給する ・埼玉工場における品質システムの構築・維持・改善を推進する ・品質システムが日本の規制当局要件、製薬業界関連ガイドライン、およびUCBの品質方針・品質基準に適合していることを保証する ・担当領域における各種KPI目標の達成に貢献する 2. メンバー支援・育成（Support and Training） ・埼玉工場全体および担当領域における品質保証活動を推進し、高品質な製品の安定供給と品質目標の達成に貢献する ・担当領域のメンバーに対し、GMP教育や品質保証に関する指導・育成を行い、組織全体の品質文化向上を支援する 3. 継続的改善（Continuous Improvement） ・オペレーショナルエクセレンス（OE）活動に参画し、埼玉サイトにおける品質および生産性の向上を推進する 4. HSE（Health, Safety & Environment） ・HSE活動を推進し、自身およびチームメンバーの安全・健康を確保する ・環境負荷の低減に向けた取り組みを実施する ポジションの魅力 ・グローバル企業の品質システムに触れながら、低分子医薬品の品質保証領域で専門性を高められる環境です。 ・埼玉工場では低分子医薬品を取り扱っており、品質システムの運用から改善活動まで幅広く携わることができます。
Job Description SummaryThe Development Quality Assurance Manager is responsible for assuring quality over-sight for activities undertaken in all Novartis entities in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and
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JD in Japanese follows. 英文の後に和文JDをご覧いただけます。 Product Engineer (Backend) - Mercari Marketplace Employment Type: Full-time Work Hours: Flextime system (no core hours) Office: Roppongi For details, see the Overview of Our Positions section of our Careers site.
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General Information Job Advert Title: 【つくば】品質保証マネージャー（アステラス製薬入社後にJV出向） Location: Tsukuba, Ibaraki Division: CMfgO Office Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 Cellafa Bioscience株式会社は、アステラス製薬が持つ細胞治療の豊富な知見と、安川電機の最先端ロボティクス技術を融合し、細胞治療の自動化・高度化を実現する革新的なエコシステムを構築するために設立されたジョイントベンチャー（JV）です。開発上の主要課題を解決し、より多くの価値ある治療候補を患者さんに届けることをミッションとしています。当社には、少数精鋭ながら高い専門性を持つメンバーが集まっており、互いに切磋琢磨しながら新しい技術の実現に挑戦しています。 現在、次世代の自動化細胞製造プラットフォームの構築を進める中で、QMS の構築・運用に中心的な役割を担う 品質保証マネジャー を募集しています。なお、本ポジションは アステラス製薬へ入社後、Cellafa Bioscience株式会社へ出向する雇用形態 です。 革新的な技術に挑む仲間とともに働き、専門性を発揮しながら成長したい方を、ぜひ私たちのチームにお迎えしたいと考えています。 セラファ・バイオサイエンス株式会社 Cellafa Bioscience Inc. is
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At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
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