At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
. ポジション概要: GQP/GMP省令に基づいて制定される品質システムの各手順書（SOPs）及び品質標準書、品質システムで作成される様式等、その文書管理業務全般の運営・維持管理を担当いただきます。規制当局の査察に対応できる強固な文書管理システムの策定及び運用を通じて、製品品質、コンプライアンスの遵守に努めます。 また、GQPの出荷判定業務において、出荷判定関連文書の一次レビューを担当いただきます。 職務内容: GQP省令、ICHQ10に基づくGQP手順書（SOPs）、品質標準書の改訂。 Global SOPとLocal SOPのギャップ分析及び国内規制要件に基づく適切な改訂。WEB文書管理システムへのSOPsの登録。 Data Integrityに基づく文書・紙媒体での保管管理、電子媒体でのバックアップ管理。それら文書の適切な廃棄。 GQP品質保証業務における年次照査報告書の作成。 GQPの出荷判定業務における一次レビュー、並びに出荷判定関連書類の作成。 その他のGQP・CMC関連業務。 職務経験: 製薬企業でGQP/GMP分野での文書管理の実務経験（3年以上） 薬機法、GQP/GMP省令に基づくData Integrityに関する基本的な知識 Word, Excel, PDF編集ソフト等を活用した文書作成・データ管理 GMP/GQPでの出荷判定関連業務の経験を有する方（GQPでの経験を歓迎） 製造販売業の品質保証部門での業務経験（3年以上を歓迎） 必要とする能力・スキル: 細部まで注意を払い、正確かつ着実に業務を遂行できる方 関係部署（薬事部、サプライ＆ディストリビューション、製造所等）とスムーズに意思疎通が図れるコミュニケーション能力 規制動向や社内プロセスの変化に対し、柔軟かつ主体的に対応できる方 英語：ビジネスレベル 資格／免許: 特になし Whatever your area of expertise, your
Company Description At Coface we make trade happen everyday Our 5,200 experts representing 80+ nationalities in 58 countries are united by a shared purpose: helping companies navigate through uncertainty by empowering them to make the right
We are seeking an enthusiastic and service-oriented Associate Technical Support Specialist to join our end-user support organization. This role is ideal for individuals looking to build foundational experience in IT operations and technical support within a fast-paced
Job Description SummaryReporting hierarchically to the Region Tendering leader, the Tendering Specialist is responsible to manage the tendering process and oversee the complete lifecycle of a bid, from identifying new opportunities to submitting a final proposal and
Job title: Medical Information Specialist Location: Tokyo About the job Our vision is to become the most trusted source of medical information to facilitate optimal health management. Our mission is to empower our customers with easy access
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Job Description: Business Overview Rakuten is Japan’s largest marketplace and an internet ecosystem offering a wide range of over 70 services, including e-commerce, travel, banking, fintech, food delivery, golf, insurance, instant messaging, and mobile networks. While
Job Description: Job Description Business Overview Rakuten is Japans largest marketplace and Internet ecosystem, offering a wide range of more than 70 services, including e-commerce, travel, banking, fintech, food delivery, golf, insurance, instant messaging, and mobile
We are seeking for an enthusiast Administrative Specialist to support various business and operational activities across Nokia Japan. This role offers flexibility in scope and responsibilities based on business needs, individual capabilities, and professional development opportunities. The
Essential Job Duties and Responsibilities: Join our team! Were hiring a Japanese-English bilingual candidate. Responsible for fulfilling all types of assistance for medical, security and logistical related requests originating through the Assistance Centre from clients and
Are you looking for a unique opportunity to be a part of something great? Want to join a 17,000-member team that works on the technology that powers the world around us? Looking for an atmosphere of
The Logistics & Trade Compliance Specialist organizes and implements a variety of responsibilities related to the flow of materials, products, services and associated systems information. Duties involve but are not limited to supply chain services, inventory control,
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer
Why PlayStation? PlayStation isn’t just the Best Place to Play — it’s also the Best Place to Work. Today, we’re recognized as a global leader in entertainment producing The PlayStation family of products and services including
Site Contract Specialist (FSO) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Specialist to join our clinical study team, supporting our Japan business
Job Posting Title:DCL Specialist Req ID:10162183 Job Description: 契約社員（1年更新、上限3年まで）、正社員登用の可能性有 Principal Responsibilities and Accountabilities Facilitate and coordinate required Disney approvals for externally facing Oriental Land Company (OLC) and Oriental Land Cruise Company (OCC) communications related to Disney Cruise
General Information Job Advert Title: 富山技術センター EHS（防火防災・安全衛生）スペシャリスト EHS Specialist / Safety & Emergency Preparedness Location: Toyama City, Toyama Division: BioPharma Manufacturing Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 環境安全担当は、富山技術センターにおける環境および安全衛生の取り組みを推進しており、マネジメントシステムに基づいた職場のリスク低減、法令・社内基準への適合、緊急時対応力の向上の実現を目指しております。関係部門や外部機関と連携しながら、実行計画の策定・実施、安全教育・訓練、防災体制の維持・改善、リスクアセスメント等を主導し、事業場の安全で安定した運営に貢献しています。特に防火・防災分野の専門性を活かし、消防計画や予防規程に基づく防災管理の中核的役割を担い防火防災訓練など行っています。 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後）
Richemont, one of the world leaders in the luxury sector, has various Houses specializing in jewelry, watches and high-end accessories. Each Maison proudly embodies a tradition of style, quality and craftsmanship and Richemont strives to preserve