What we offer Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you
CooperVision Japan (CVJ) is the largest operating business in the APAC region, based in Tokyo and is the second largest single country businesses in worldwide. Japan RA Senior Specialist (hereinafter referred as the RA Senior Specialist) shall be
CooperVision Japan (CVJ) is the largest operating business in the APAC region, based in Tokyo and is the second largest single country businesses in worldwide. Japan RA Specialist (hereinafter referred as the RA Specialist) shall be responsible for
About Remote Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Job Overview 综述 It’s an experienced role and mainly responsible for logistics activities coordination and 3P service provider management, Logistics Cost dispute, Customer Complaints investigation, project management, etc. Responsibilities 职责 Logistics coordination Shipment fulfillment- Ensure truck
Job title: PMS Planning and Management Specialist • Location: Tokyo, Japan - About the job As a PMS Planning and Management Specialist within our Regulatory Affairs team, youll help ensure the safety and integrity of new medicines by designing
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
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HSBC Asset Management (“AM”) Product Group is responsible for the strategic and commercial development of AM Product manufacturing capabilities including Development, Management, Governance, Support and Mandate delivery across all Global Markets. The product function is expected
Participate and support internal and/or external audits, inspections, or surveillance to demonstrate compliance with the regulations or standards such as QMS Ordinances No.169, ISO13485, and MDSAP audit requirements. Organize and review processes, Quality Manual, Standard Operation
HSBC Asset Management (“AM”) Product Group is responsible for the strategic and commercial development of AM Product manufacturing capabilities including Development, Management, Governance, Support and Mandate delivery across all Global Markets. The product function is expected
At Amazon Web Services (AWS), Security is our highest priority. The AWS Security Assurance team is responsible for demonstrating the security controls of services offered by AWS. At our scale, we invent new ways to provide
Overall Purpose of the role Regulatory Affairs in Japan is responsible for the local regulatory affairs function, ensuring compliance with Japanese regulatory requirements, and aligning strategies with global objectives. This role leads regulatory strategy in Japan for specific portfolio projects,
Job Description This role will be responsible for working closely with the Senior Director of Business Development (Corporate Strategy) and assisting in leading and overseeing strategic planning initiatives, with a focus on mergers and acquisitions (M&A)
AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we’re the people who keep the cloud running. We support all AWS data centers and all of the
Essential Functions & Accountabilities: Overseas end-to-end AR processes, including billing, collections, cash applications and dispute resolution. Monitor AR aging, customer credit exposure, and collection performance, ensuring timely cash inflows. Collaborate with GBSC and local
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
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