職務の目的および主な業務内容 Job Purpose & Main Responsibilities バッチレビューワー、出荷判定責任者の業務内容は、以下のようなものである。 ・今市工場製造/包装品および搬入原資材、中間バルク、最終製品のバッチドキュメントの確認業務を行う。 ・出荷判定責任者として「出荷可否判定手順書」に基づき、製造管理及び品質管理の結果を適切に評価し、製品の出荷の可否を決定する業務を行う。 ・搬入製品について書類の不備、異常があった場合は、供給側とコミュニケーションを取り、状況を確認する。 ・生産工程、GxP、EHS、有効性、安全性に関連する教育を受講する。 ・製造及び試験におけるシフトの間、物理的立ち合いを支援する。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要要件 Required Skill, Experience, Etc. 必要な条件Required スキル ・QMS/EHS概論を理解。 ・業務手順書を作成。 ・薬機法、GMP省令に関する知識を有している。 ・医療機器の出荷判定を行う者は、QMS省令に関する知識を有している。 ・出荷判定を行う製品の製造管理、品質管理に関する知識を有し、製品標準書の内容について充分な理解がある。 経験 ・製造管理又は品質管理業務に3年以上従事した経験がある。 学位/資格/語学力 ・高卒以上またはそれに値する知識/経験を有する。 ・日本語でのコミュニケーション能力 ・英語でのコミュニケーション能力（読解、簡単なメールコミュニケーション） 望ましい条件 Preferred スキル ・SAPの知識 経験
Our established 9-op practice in SE Edmonton is growing and we are looking for a part-time Associate Dentist to join the Mill Woods Town Centre Dental Clinic team. We are looking for a Dentist skilled in
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Key Responsibilities Assists in delivering technical presentations, negotiating product specifications and creating product configuration proposals. Assists in identifying opportunities to solve complex opportunities for customers. Assists account sales to close business on specific products and/or services.
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Who is Tenable? Tenable® is the Exposure Management company. 44,000 organizations around the globe rely on Tenable to understand and reduce cyber risk. Our global employees support 65 percent of the Fortune 500, 45 percent of
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Sales Job Details About Salesforce We’re Salesforce, the Customer
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的： 臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。 業務内容： 海外本社の関係部門（特にGlobal SDL）と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。 開発戦略立案：日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う 臨床試験の運営：Study実施の具体的方針決定（各種Study levelでの意思決定）、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理 業務全般及び組織運営にかかわる以下の活動を担う。 各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力（専門的技能・知識等）の向上を担う（組織開発、人財育成 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要要件 Required Skill, Experience, Etc.
About the Team OpenAI’s mission is to ensure that general-purpose artificial intelligence benefits all of humanity. Our Communications team includes PR/media relations, employee communications, events, design, and other external-facing functions. This team’s ethos is to support OpenAIs
Location: Tokyo, Tokyo, Japan Job ID: R0048517 Date Posted: 2024-05-07 Company Name: HITACHI ENERGY JAPAN, LTD. Profession (Job Category): Communications & Corporate Affairs Job Schedule: Full time Remote: No Job Description: General information: Be a part of
JOB SUMMARY Shapes and executes an overall marketing strategy. Communicates this strategy to the marketing team and other business units. Coordinates with sales management in order to ensure alignment of marketing and sales strategies. Evaluates past
Job Purpose The Ethics & Compliance Officer Japan & South Korea is responsible for implementing strategic goals, planning efforts, managing projects and providing measurable inputs into processes, standards and operational plans for the Ethics & Compliance
Secure our Nation, Ignite your Future ManTech is seeking a Field Technician (CI/HUMINT) to join our team in our USMC customer in Okinawa Japan, This position requires an ACTIVE DoD TS/ SCI Security Clearance. ManTech International
Job Summary Initiating the Environmental, Safety, and Health programs and policies in our organization, ensuring compliance with local regulation, and keep no TRR. In this Role, Your Responsibilities Will Be Developing and implementing ESH strategies, procedures
About The Job: FactSet Research Management Solutions (RMS) help our clients optimize the collection and publication of research. RMS Partners is a suite of workflow-driven solutions tailored to the needs of our clients to boost cross-firm
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
Pre-assembly of offshore wind turbines aims to optimize the use of installation vessels reducing the number of lifts needed in offshore conditions and ensure the assets mechanical completion is achieved in a controlled environment. Pre-assembly of
#WeAreCrowdStrike and our mission is to stop breaches. As a global leader in cybersecurity, our team changed the game. Since our inception, our market leading cloud-native platform has offered unparalleled protection against the most sophisticated cyberattacks.
You will be part of a growing team of experts in Network Infrastructure products, who will demonstrate & integrate the latest technologies and inventions for our customers. We are looking for a person that can work
