At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and
The Head of Legal & Compliance of Manulife Investment Management (Japan) is responsible for leading the legal and compliance function for the asset management business in Japan. This role oversees a team of Legal and Compliance professionals and is
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique
職務の目的および主な業務内容 職務目的 薬機法およびGMP省令を遵守し、「主な業務内容」に記載された関連手順書に従って業務を遂行する。加須製造業品質部門の一員として、品質保証上の役割と責任を果たすとともに、製品出荷を遅滞なく確実に実施する。 また、将来的には製造管理者の職務を担う可能性を踏まえ、製造業全体の業務および品質管理体制を体系的に理解し、適切な管理が行える人財となることを目指す。そのため、広い視野と責任意識を持って業務に取り組み、継続的な成長と組織への貢献を図る。 主な業務内容 加須製造業の一員（将来的には製造管理者も視野に）として： 加須製造業の品質部門及び製造部門と連携・協働をし、業務を遂行する 関連部署と合意したスケジュール通りに、GMP及びGQP出荷判定を行う 出荷判定に加え、加須製造業における試験検査、文書及び記録管理、バリデーション、定期的製品照査、変更管理、逸脱処理、品質情報処理、回収処理、自己点検、外部委託業者管理、教育訓練、薬事対応などを遂行する 当局査察の際は、事前準備、当日の対応及び指摘事項に対するアクションを遂行し、加須製造業の業許可を維持する 逸脱や製品不良などが生じた際は、海外製造所と社内関連部署、製品によっては他社製造販売業者にも報告を適切に行い、品質と法令遵守を考慮した最適解を立案し、関係者へ説明をする GSK QMS（Quality Management System）が新設や改訂された際、加須製造業への影響評価を行う ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要な条件 スキル 自部門や関連部署と適切に連携しながら業務を推進するためのコミュニケーション力やリーダーシップ力、及び、課題解決に向けて選択肢を提示できる問題解決力を有すること。 薬機法やGMP省令に関する理解を有すること。 経験 品質関連業務の経験や知識 学位/資格/語学力 薬剤師免許の所持 英語：メールやCallにて、海外の製造サイト等とコミュニケーションが取れる程度の英語力 望ましい条件 スキル AIツールの活用等、新たなアプローチを適切にリスク評価した上で導入し、継続的な業務改善を推進できるマインドを有すること。 経験 GMP、GDPまたはGQP関連業務の経験 当局査察の対応経験 *就業場所： 東日本物流センター 埼玉県加須市北大桑152-1 *リモートワーク：不可 SkillsData
Its fun to work in a company where people truly BELIEVE in what theyre doing! Were committed to bringing passion and customer focus to the business. If you like wild growth and working with happy, enthusiastic
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is
Job Description SummaryThe Senior Systems Engineer provides advanced systems engineering leadership for diagnostic ultrasound products and platform development, with responsibility for system requirements, design analysis, subsystem integration, technical tradeoff decisions, risk management, and system verification and
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Exceptional Hospitality Starts with You Picture yourself brightening someone’s day. When you join our Hotels team, that’s exactly what you’ll do every time you come to work! Youll be the brains behind the kitchen operations, making
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Title: Quality Assurance Specialist Introduction about us: At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative
Location(s) Kanoya, Kagoshima Company Molex Career Field Procurement & Sourcing Job Number 191765 Your Job Sourcing Engineer (Indirect) / ソーシングエンジニア (間接材) Our Team Indirect Sourcing sources indirect materials (e.g., MRO, machinery, outside services, facilities) with required
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At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique
Job Profile Description The Head of Japan Data Office is responsible for leading the organization’s data strategy, governance, and data management capabilities to enable trusted, high-quality, and business-driven use of data across Manulife Japan. This role
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
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Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
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