Job Description: Department Overview This department is responsible for maintaining and improving service quality and compliance across Rakuten Mobile shops nationwide. In this position, you will manage and improve operational quality, including at retail locations and outsourced partners,
. 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
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
REQUIREMENTS / CANDIDATE PROFILE Education and Experience • 2-year degree from an accredited university in Human Resources, Hotel and Restaurant Management, Hospitality, Business Administration, or related major; 2 years experience in the human resources or related
Job Description: Business Overview Rakuten Group provides more than 70 services in a wide range of fields, including e-commerce, travel, digital content, and other Internet services in Japan and overseas, as well as financial services such
Key Accountabilities Country Quality System management Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance, regulatory and clinical. Deviation and
Introduction to the job The Supplier Quality Engineer (SQE) for MLP Optics Competence is responsible for ensuring supplier capability, quality performance, and manufacturability of complex optical components and assemblies supporting ASML products. The SQE works closely with Development
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
Technical Quality Expert - Tokyo Osaka - Office Hybrid Remote At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships,
Alternative Investment Solutions Fund Administration Manager Real Estate –Investment Control Officer, Japan Role Overview The Officer will support the delivery of Investment Control/Management services for the Japan portfolio. The role will have hands on responsibility for investment level
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
Job Title:Senior Engineer, Materials Quality Engineering Job Description: Senior Engineer, Materials Quality Engineering We are seeking a dynamic Senior Engineer to join our Materials Quality Engineering (Supplier Quality) team supporting our regional supplier base and Japan manufacturing operations. In this
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
Mujin is a global leader in industrial automation, redefining supply chain efficiency through MujinOS—our intelligent operating system for robotics. At our core is Machine Intelligence (MujinMI), a unique approach that leverages real-time digital twins and advanced
Job title: Pharmacovigilance Quality & Compliance Manager Location: Tokyo - Job role Fulfill responsibility that processes to comply with local PV regulations and the global procedures are implemented, documented and followed locally (QD management, self-inspection, etc.) Fulfill
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
職種 正社員 職務明細 国内外大手2社の合弁会社で､高い安定性を実現！ ビルメンテナンスの国内パイオニアであるグローブシップ㈱と、世界の総合施設管理大手の仏ソデクソ (Sodexo S.A.) との合弁会社が、｢グローブシップ･ソデクソ･コーポレートサービス株式会社｣です｡ 両社のノウハウやネットワークを生かして､国内の工場や事業所向けに設備管理や清掃、警備､備品調達など､ 総合施設管理（IFM: Integrated Facility Management ）事業を展開｡ これにより､今まで以上のサービス展開､質の向上､安定した取引を実現させています｡ 当ポジションの方には、埼玉県熊谷市に位置する、当社の取引先である外資系製薬会社の妻沼工場に当社メンバーと共に常駐していただき、当社が取引先に提供している施設管理業務サービスによって発生する品質管理業務をご担当いただきたいと考えております。 詳細は下記の業務内容をご確認ください。 スキル・資格 【必要スキル】 - 生産設備における品質管理の実務経験 - 日本語での文章作成能力、校正力 - 顧客やチーム内での円滑なやりとりのための日本語コミュニケーション力・折衝力 - 品質問題を調査・解決するための分析能力・提案能力 - 英語力（読み書き） 【歓迎スキル】 - 施設管理および工場生産分野での実務経験 - 医薬品製造要求事項および規格の知識 - ビジネス英会話
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples