Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance
Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年） ・GVP対応（情報収集、当局報告、記録書作成保管等） ・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等） ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬事規制（特に安全管理業務）に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Job Description Responsibilities Functionally responsible and accountable for the following areas: Facilities management for 6 facilities in Japan Repairs, maintenance, improvement Access/badge management Office supplies, mail service Office layout, design, planning, seat assignments On-site Contingent Worker Management and Administration
In our always on world, we believe its essential to have a genuine connection with the work you do. Due to our continued growth and customer demand, we are hiring a Project Support Specialist to support
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Our client’s Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organizations, providing their clients with the ability to keep up with the ever-changing digital world
Job Summary Provides support by addressing customer requests, inquiries, and/or questions through email, phone, or live chat. Responsibilities Customer Support Provides support by addressing customer requests, inquiries, and/or questions through email, phone, or live chat troubleshoot,
Data Center Customer Operations Engineer III / データセンターカスタマーオペレーションエンジニア III Equinix is the worlds digital infrastructure company, operating 240+ data centersacross the globe andproviding interconnections to all the key clouds and networks. Businesses need one place to
Intersoftkk Inc. is a global Information Technology and Services Company offering all sorts of web and mobile application design & development, Salesforce & SAP enterprise solutions. We are a leading Digital Transformation Service firm with a
Global IT Hardware Maintenance Services for High End Server, Storage Systems and Medical Equipment Maintenance Support. Inwinteck has started its operations in 2015 and has been growing exponentially in providing On Call / On-Site break fix support
Intersoftkk Inc. is a global Information Technology and Services Company offering all sorts of web and mobile application design & development, Salesforce & SAP enterprise solutions. We are a leading Digital Transformation Service firm with a
Job Details What you will do Recruits, Builds, optimize, and maintain the channel partner community and go-to-market program(s) to maximize profitability and market reach. Implements core channel programs, tools, plans, incentives to produce positive channel results,
Our client is an AI Driven Technology (SAAS) company with that provides Transport Smart Solutions for client in Japan, Singapore, Philippines, Thailand, Indonesia, Australia & Vietnam. About the Opportunity: Opportunity to work with multinational members from
Main Responsibilities: Reporting to IT Operation Manager, this is a hands-on role working a high pressure 24/5 financial trading environment. Ensuring 1st line smooth support of day to day technical operations of trading floor will be
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
DESCRIPTION Data Center Senior Construction Manager The Data Center Senior Construction Manager (CM) is responsible for managing some of the most technical, cost efficient, and fast paced construction project schedules achievable. Amazon Construction Managers are constantly
DESCRIPTION As a Head of Startup Ecosystem in Japan, you will help shape and deliver on a strategy for AWS to build mind share and broad use of its cloud computing platform among startups. The global
Our client is a largest global System Integrator company. They are now building new division, which is a convergence of data and cloud to support Japanese enterprises in the cloud, such as ecosystems in AWS, Azure and
