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
Control Risks exists to make our clients succeed. We are a specialist risk consultancy that helps to create secure, compliant and resilient organisations in an age of ever-changing risk. Working across disciplines, technologies and geographies, everything we
Abhidi Solutions, is an emerging, end-to-endinformation technology services and solutions provider, working with leading organizations from the Financial Services, Technology, Communications & Media, Manufacturing & Retail, Energy and Utilities and various other domains. Abhidi delivers highly responsive and
Our client can effectively, efficiently, and securely shift a companys IT operations management to remote work and SaaS-centric design and operation without replacing any of the hardware and software currently in use. Its core technology is orchestration,
Intersoftkk Inc. is a global Information Technology and Services Company offering all sorts of web and mobile application design & development, Salesforce & SAP enterprise solutions. We are a leading Digital Transformation Service firm with a rich
Intersoftkk Inc. is a global Information Technology and Services Company offering all sorts of web and mobile application design & development, Salesforce & SAP enterprise solutions. We are a leading Digital Transformation Service firm with a rich
Our client’s Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world by
Our client’s Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organizations, providing their clients with the ability to keep up with the ever-changing digital world by
Our client’s Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organizations, providing their clients with the ability to keep up with the ever-changing digital world by
