■主な業務内容: 英製薬大手AstraZenecaの一員として、Japan Market Company におけるGMP/GDP Quality Leadを務め、GMPおよびGDPの実施及び遵守状況を確認し、AZ-Globalの要件を満たすための更新・改善を行う。 主な担当予定業務: ・グローバル品質マニュアル、cGxPおよび国内規制に従い、グローバルGxP組織と連携し、日本市場におけるQuality Leadとして、品質システムの構築と維持管理および改善を行う。 ・医薬品品質システム（CAPA, Change Control, Deviation, Self-Inspection, Training, Complaint, Documentationなど）や供給業者管理の運用および継続的な改善を行う。 ・グローバルGxP組織がリードするプロジェクトに参画し、GMP/GDP関連分野のイニシアチブを取る。 ・部門横断的なGxPに関連する重要課題、実施部門単独では解決困難な課題について、施策立案、実行および主導を行う。 ・発出される品質関連法規等への対応を行う。 経験 Experience ■必須 Mandatory ・医療用医薬品又は医療機器業界での品質保証の経験(工場QAとしてのGMP及びGDP経験：少なくとも２～３年以上)、 医薬品品質システム(PQS)の責任者として運用管理・改善等の経験 ■歓迎 Nice to have ・医療用医薬品に関するGMP及びGDP経験：５年以上 ・医薬品品質システム(PQS)の責任者として運用管理・改善等の経験 ・GMP又はGQPのQAでのマネジャー経験 ・海外での業務経験 資格 License
職種 正社員 職務明細 About LOEWE Created in Spain in 1846, LOEWE approaches 175 years as one of the world’s major luxury houses. Since 2013, under LOEWE’s creative director, Jonathan Anderson, the brand has started a new
At Maersk, we are determined to put our customers’ needs first. Global Markets are evolving fast, and we aim to connect, protect, and simplify our customers’ supply chain in response to these changes. We are on
Basic purpose of the job Delivers project management support to the asset team and next–level teams with the focus on asset strategy execution and asset progress. Coordinates the interactions with all key stakeholders, local and Global
• Establish and maintain the appropriate organization in order to ensure delivery of job objectives and fulfil responsibilities. • Train and develop individuals by coaching and using the Performance Management Process in order to maximize their
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
Career CategoryQuality Job Description Description Quality and Compliance oversight of External sites. Ensure External site activities are in alignment with applicable product CTA /Marketing Application. Key Responsibilities Serve as the main Quality point of contact related
Valeo is a tech global company, designing breakthrough solutions to reinvent the mobility. We are an automotive supplier partner to automakers and new mobility actors worldwide. Our vision? Invent a greener and more secured mobility, thanks
General Information Job Advert Title: VP, Transformation Managing Principal Location: Japan Division: Transformation Office Employment Class: Permanent Description Do you want to be part of an inclusive team that works to develop innovative therapies for patients?
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
Job title – Associate Manager, Engineering/SHE, Taste Location – Ibaraki, Japan Job model – On Site To lead and operationalise Safety, Health, Environment and Security (SHE&S) management system to improve on SHE&S awareness and culture at
Report to: Commercial FP&A Director （who reports to Japan CFO） Responsibilities: FPA: Execute monthly management reporting process and timely provide clear, concise and accurate performance analyses and reports FPA: Assist Commercial FP&A Director and Japan CFO
Company Description Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come
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
JOB DESCRIPTION: Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. This testing provides crucial information for the treatment and management of
Location:Tokyo, Tokyo, Japan Job ID: R0075621 Date Posted:2025-02-04 Company Name:HITACHI ENERGY JAPAN, LTD. Profession (Job Category):Quality Management Job Schedule: Full time Remote:No Job Description: Mission Statement: Ensures support to the project management team regarding all quality
The demand-planning organization of the company is responsible for the development of a demand forecast which is the basis for company investments. The primary role of the lead cluster market demand planner is to develop a
Responsible for the development of a demand forecast which is the basis for company investments. The primary role of the lead cluster market demand planner is to develop a demand forecast using data such as sales
Objectives of the Position Design and develop agronomic models for new functionalities for digital tools based on locally available trial results Enhance agronomic models for existing functionalities for digital tools based on locally available trial results
Key responsibilities： Ensure to build authentic external engagement plan through quality control and cross functional alignment including region/global team Lead for public communication and engagement with PLHIV by implementation of external communication and educational program Responsible
