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)に係る品質保証業務 · 職務内容: · 他の品質保証担当者と連携し、Quality Manage System (QMS)の運営、維持管理の実施していただきます 。 · ・QMS関連文書の新規作成及び改訂 · ・関係部門との協働による新製品の市場上市計画の策定と実行 · ・法定表示ラベルの作成、改定 · ・製造販売開始および変更時におけるリスク分析の実施 · ・内部監査および供給業者の評価の実施 · ・国内製造委託業者の管理 · ・不具合発生時の海外製造所への報告、連携による原因調 ...

■職務内容 · 薬機法や安全性に関する規制及び社内の標準操作手順(SOP)を遵守し、国内外の医薬品、医療機器、 · 再生医療等製品に関する有害事象、副作用情報、不具合情報の収集、評価、報告を行う業務です。 · 具体的には下記の業務です · ・国内における治験薬・製造販売後製品の安全性情報、文献学会の一次評価・CIOMSや文献学会情報等による海外(英語)安全性情報の一次評価、和訳・MRへの再調査指示業務サポート・医薬品医療機器総合機構への(医薬品)副作用、研究報告、措置報告、不具合報告書(案)の作成・経験に応じて、チームリーダーやクライアント窓口などを担当 ...

JOB TITLE:Senior Robotic Startup Specialist · DEPARTMENT:Surgical Robotics · REPORTING TO:Country/Regional Sales Director · LOCATION: All Over Japan · ********************************************************************************************** · "Careers that Change Lives" ...

■クライアントのニーズと要件を確認し、ベストプラクティスや共通のアプローチについてアドバイスを提供するコンサルティングをお任せいたします。 · ◇製品提供の1つまたは複数の領域で製品の導入の専門知識を提供 · ◇クライアントのニーズと要件を評価し、ベストプラクティスや共通のアプローチについてアドバイスを提供 · ◇クライアントの要件に基づいてソリューションオプションを特定し、仕様書を作成 ...

You will be responsible for a variety of duties as Senior Manager Global Patient Safety. · A typical day may include: · Authors new and updates to SOPs and Working Instructions and conduct related training. · Standardize on PV/PMS process and workflow, and support to implement a ...

Job Summary: · Red Hat Japan is seeking a Senior Communications Specialist who will be based in our Tokyo office. This is a multi-disciplined role that covers public relations, analyst relations and internal communications programs for Red Hat Japan. As the country communication ...

Description · : Department Overview · This role belongs to the IT Security Group within the Information Security & Privacy Governance Department. Our objective is to develop measures to ensure that our organizational data remains secure. While doing this, we often partner with ...

Are you a customer-obsessed builder with a passion for helping customers achieve their full potential? Do you have the business savvy, Enterprise Applications, Migration and Modernization (EAMM) background, and sales skills necessary to help position AWS as the cloud provider of ...

Description · : Key Responsibilities · • Account management on new/existing customers and distributors to generate sales and reach to the target plan · • Account plan execution with leadership among production team, supply chain/logistics/CSR, and marketing managers to initiate ...

MAIN PURPOSE OF ROLE · Supervises the day to day activities of staff that comprise the accounting function to ensure including accounts payable, accounts receivable, joint interest billings, revenue and asset accounting. · Responsibilities may include other accounting functions s ...

Short Intro and About the Job · PRIMARY PURPOSE OF THE ROLE : · As a Procurement Excellence senior specialist, you will play a pivotal role in optimizing and enhancing the procurement processes and strategies within the organization. This position reports directly to the Senior ...

Primary Function/Primary Goals/Objectives · The Contract Manufacturing Specialist is the key point of contact between Abbott and the assigned Contract Manufacturer. Primary focus of this role is to work on New Product Introduction (NPI) Projects with the Contract Manufacturer wh ...

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are tran ...

As a Senior HR Specialist in Japan, youll be working at the very heart of our People Team, supporting and partnering with our business team leads and all Wolt employees in country operations across Japan. You will lead all HR operations initiatives, work closely with the local H ...

Description · Dow has an exciting opportunity for a Senior Sales Specialist in Dow Industrial Solutions (DIS) business, located in Tokyo, Japan. · You will work with the team and contribute to the business growth and differentiation of DIS business. · Job is an account managemen ...

Senior Specialist, People Business Partner · Location: Tokyo, Japan · Address: Nomura Fudosan Nishi Shinjuku Bldg 8F, 8-4-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo東京都新宿区西新宿8-4-2野村不動産西新宿ビル8階 f · Our mission is to unlock human potential. We welcome you for who you are, the backgroun ...

CORE JOB RESPONSIBILITIES · Responsible for the flow of day to day warehouse activity, including receiving, inspection, inventory management, shipping, delivery through freight forwarder networks. · Communication to work with global and domestic team on internal and external cust ...

We help the world run better · Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, an ...

A regional renewable energy developer is currently looking for a talented HSE professional to join their growing HSE team in Tokyo. · As an HSSE Specialist, you will play a crucial role in supporting the HSSE Manager by coordinating the development, updating, and implementation o ...

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless ...