Work Schedule Other Environmental Conditions Office Job Description 職務内容: 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）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年） ・GVP対応（情報収集、当局報告、記録書作成保管等） ・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等） ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬事規制（特に安全管理業務）に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Office, Will work with hazardous/toxic materials Job Description 【職務概要】 フィッシャークリニカルサービシズで決められた手順と方針、cGMP、cGDP、および規制要件に従って、治験薬の保管・配送を品質面から確立すること。 フィッシャークリニカルサービシズの決められた手順と方針、cGMP、cGDP、および規制要件に従って、FCSジャパンの品質システムを維持すること。顧客、社内外の関係者と品質関連事項について連絡を取り合う。 【業務内容】 臨床試験のサプライチェーン活動に適用される社内基準、国内および国際的な品質およびGMPガイドラインに求められるコンプライアンスを確保し、重要な改善を推進する。 顧客、サプライヤー、社内関係者に対し、規制・品質に関する指導・助言を行う。 社内外の監査に対応し、監査での指摘事項や改善をフォローアップする。 品質マネジメントシステムで求められる品質活動を実施する。 業務に影響を及ぼす規制・品質問題に関連する事項を見出し、その解決策対応策についてパートナーとして関わる。 プロセスパフォーマンス、製品品質、医薬品品質システムの品質レビューに責任を持ち、継続的な改善をサポートする。 品質問題を適切なレベルの経営陣に提起するために、エスカレーションプロセスを理解し、タイムリーで効果的なコミュニケーションを心がける。
Job Description Semiconductor production system development project, operation support, maintenance work 1) Promote the integration of production systems existing in domestic and overseas semiconductor production factories 2) System planning, design, development, introduction, and deployment of production
企業概要 At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible. At our core, Western Digital is a company of problem
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
求人内容 Production Engineering specialist. This person will lead engineering activity includes following items. 1. FS, design for new production line and facility, make URS based on latest GMP guideline and operation excellence 2. Based on business
Company Description Software and Digital Solutions business Unit (SDS) is responsible for growing Digital Business and operates in 4 regions – APAC, Japan, Europe and North America. The business is structured in every region as a
Company Description Company Overview Third Bridge is a market-leading investment research firm. We provide integrated solutions for the world’s top investors and business leaders to help them make smarter and faster decisions. No other company in
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new
Location(s): Japan City/Cities: Tokyo Travel Required: 00% - 25% Relocation Provided: No Job Posting End Date: June 14, 2024 Shift: Job Description Summary: We are looking for an experienced microbiologist to oversee and manage all microbiological
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Location(s): Japan City/Cities: Tokyo Travel Required: 00% - 25% Relocation Provided: No Job Posting End Date: June 14, 2024 Shift: Job Description Summary: 【Main Activities】 Climate pillar: Develop the most optimum mid- to long-term decarbonization strategy
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Job Description Summary Job Description Summary The Executive Site Leader is responsible for developing a vision and leading site-wide operations at GE Healthcare’s site around GE Healthcare imperatives, and meeting all operational defined targets such as
As a Cloud Solution Engineer, your main responsibilities will be to propose and support cloud usage for major enterprises. You will work closely with the sales representative from a technical perspective and collaborate with product specialists
