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Senior QA Specialist
3週間前
Thermo Fisher Scientific Tokyo, 日本 フルタイム医療機器、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 ...
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Medtronic Tokyo, 日本JOB TITLE:Senior Robotic Startup Specialist · DEPARTMENT:Surgical Robotics · REPORTING TO:Country/Regional Sales Director · LOCATION: All Over Japan · ********************************************************************************************** · "Careers that Change Lives" ...
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(株)UL Japan Tokyo, 日本■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 ...
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Rakuten Tokyo, 日本 フルタイム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 ...
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Red Hat K.K. Tokyo, 日本 フルタイム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 ...
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Amazon Web Services Japan GK Tokyo, 日本 フルタイム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 ...
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DOW CHEMICAL JAPAN LIMITED Tokyo, 日本 フルタイム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 ...
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Abbott Laboratories Shinjuku-ku, 日本 フルタイム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 ...
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Danone Tokyo, 日本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 ...
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Abbott Tokyo, 日本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 ...
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Wolt Tokyo, 日本 フルタイム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 ...
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Stryker Tokyo, 日本 フルタイム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 ...
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DOW CHEMICAL JAPAN LIMITED Tokyo, 日本 フルタイム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 ...
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Zendesk Tokyo, 日本 フルタイムJob Description · Job Summary: · We are in search of a dedicated and experienced Workplace Specialist to optimize our office operations in Japan. The ideal candidate will be proficient in reception duties and have a strong background in workplace management, ensuring efficient ut ...
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Wiley Tokyo, 日本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 ...
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Abbott Laboratories Tokyo, 日本 OTHERCORE 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 ...
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SAP Tokyo, 日本 Regular フルタイム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 ...
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Stryker Tokyo, 日本 フルタイム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 ...
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DOW CHEMICAL JAPAN LIMITED Tokyo, 日本 フルタイムAt Dow, we believe in putting people first and we're passionate about delivering integrity, respect and safety to our customers, our employees and the planet. · Our people are at the heart of our solutions. They reflect the communities we live in and the world where we do busine ...
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Danone Tokyo, 日本Short Intro and About the Job · PRIMARY PURPOSE OF THE ROLE · The Reward & OD Manager/Senior Specialist is responsible to design, implement, and manage a comprehensive rewards and organizational development strategy that aligns with the company's business objectives. This role ...
説明
Primary Function
Individual contributor that works under limited supervision.
- Applies subject matter knowledge.
- Requires capacity to understand specific needs or requirements to apply skills/knowledge.
Core Job
Primary responsibility is ensuring implementation of quality plan
- Implement quality assurance regulations.
- Write and revise standard operating procedures.
- Support and facilitate audits and regulatory inspections.
- Support Quality Systems are in place that meet the requirements for business needs, local regulatory authorities and Abbott Quality Assurance.
- Various specific assignment may include different aspects of quality system such as Internal audit, Training, CAPA investigations, Complaint and Product action, Documentation control, Supplier Management, Material and Distribution control, Validation, Importation and Lab testing, Distribution control, and as well as GQP requirements.
- Support Quality Assurance Manager in supervision of all quality control aspects of the process (laboratories studies, clinical research, testing, operations).
- Various specific assignment may include different aspects of quality control such as raw material testing, finished product testing, batch release review and QA hold.
- Need to be qualified as internal auditor minimally.
- Support implementation of new regulations.
- Support quality training.
Education
Degree in chemistry or pharmacy or other scientific background
Background
Quality Assurance in Pharma
Required Functional Competencies
English (if possible)
Accountability Scope
Core Jobと同じ
Required Training
Japanese Pharmaceutical GQP/GMP /医薬品GQP/GMP