This is what you will do: 【Manager, Japan Country Quality】 製造販売業者の信頼性保証部員として、当該役職者はGlobal AlxionのポリシーおよびSOPに従い、GQP QAグループを管理する。また、QMS管理業務、APJ手順書作成/制定、各品質協定規格締結/遵守、GMPコンプライアンス調査、製造所認定業務などの主要な活動を通じて、適正品質管理（GQP）およびGMDPの準拠を確保することを主たる責務とする。さらにAPJが製造販売業者として顧客クレーム対応も管理する。そのために社内外顧客、即ち、安全性管理部門、サプライチェーン、メディカル、薬事、CMC、営業・マーケティングなどと部門横断的に協働し、所轄当局や共同販売会社と連携・調整を行う。 You will be responsible for: ・開発品から市販後製品としてのGMDP/GQPプロセスのコンプライアンス管理 市販後製品の品質管理システム管理 製造販売業体制管理/主に品責・総責のサポート業務 市販後製品の品質関連業務 You will need to have: ・各種プロジェクト会議を主宰しリードする QA週例会議において、担当業務におけるトピックを速やかに報告する。 QA月例会議において、品質関連情報のトレンド分析を行い、必要な場合と是正を推進する。 QMS会議/主に変更・逸脱会議/事案に対する対応方針などの検討する Global組織とのコミュニケーション多数に参加し、APJの情報を報告・協議する。 We would prefer for
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on
What Cognite is: Relentless to achieve Cognite operates at the forefront of industrial digitalization, building AI, and data solutions that solve the world’s hardest, highest-impact problems. With unmatched industrial heritage and a comprehensive suite of AI
GENERAL INFORMATION Become the wind beneath our wings in all pharmaceutical and drug-related issues. We are looking for a QP / Qualified Person / Souseki (m/f/x) Location: Yokohama Starting: at the next possible date YOUR PROFILE The
JOB DESCRIPTION: About Abbott: Abbott is a global healthcare leader committed to helping people live more fully at all stages of life. At Abbott, were committed to helping you live your best possible life through the
メルクと一緒に、あなたの力を発揮しよう！ 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？ 患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。 Your Role In this pivotal role, you will shape and oversee the local quality strategy for Japan, protecting patients and supporting reliable access to medicinal products. You will lead quality and compliance activities
Job Description SummaryAs a Manager, Global Clinical Supply Group, you will play a critical role in ensuring uninterrupted clinical trial supply across Japan. Working closely with global and local stakeholders, you will develop and execute clinical
Plant Engineer Shiga YOUR TASKS AND RESPONSIBILITIES: - Lead and execute projects involving the installation, major renovation, and upgrading of manufacturing equipment, facilities, and utility systems at the Shiga Plant. - Ensure compliance with relevant regulations and
Career CategoryMarketing Job Description HOW MIGHT YOU DEFY IMAGINATION? Amgen is a global leader in biotechnology with a history of more than four decades of pioneering breakthroughs. Our commitment to science has led us to discover
Job Purpose Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice, Warehouse Job Description highly motivated individual to join the DSA team to ensure all customer’s orders are properly handled in an accurate and timely manner and accuracy. By listening to customers
Job Title: Regional Sales Manager NEA - PI Location: WMFTS - Japan - Tokyo Location Type: Hybrid Website: https://www.wmfts.com/en/ Group: https://www.spiraxgroup.com/ Watson-Marlow Fluid Technology Solutions is part of Spirax Group, a FTSE100 and FTSE4Good multi-national industrial
Job Title: Sales Leader – IT Services (Life Sciences) Location: Japan Market Focus: Japan / North East Asia Experience: 15–20 Years Salesperson – Life Sciences SRM Tech Delivery team is rapidly scaling up to meet the
Our Mission At Palo Alto Networks®, we’re united by a shared mission—to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking.
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
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
Appealing Points: Support critical pharmaceutical manufacturing applications, ensuring stable system operations through incident management, troubleshooting, and user support. Gain exposure to regulated IT environments, working with industry practices such as GMP, CAPA, CSV/CSA, ITIL, and SLA management. Collaborate
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we