安全管理責任者- Safety Control Manager/Pharmacovigilance
(PV) system, fulfilling the duties of a Marketing Authorization Holder (MAH). Ensure compliance with local...
(PV) system, fulfilling the duties of a Marketing Authorization Holder (MAH). Ensure compliance with local...
社名(支店名)・店舗名:めい動物病院 急募!動物看護師!ブランクがあっても大丈夫!(経験者優遇)動物と人が好きな方にぴったりの職場です! 最寄り駅:JR南武線 武蔵新城駅 徒歩2分 勤務時間:08:30~19:30 勤務時間備考:週休二日制or三日制を選択可能。 有給休暇有 年末年始 仕事内容:今年度(2023年)より動物看護師が国家資格になりました。それにより、より人間の看護師に近しい業務も担えるようになりました。基本は受付、診療補助、手術補助、入院患者のお世話、...
一緒に働きましょう。 The Role & Department As MAH QA, implement and promote GQP operations (release control, manufacturing site control... inspections, responding to PMDA inquiries when applicable, preparing product quality standard document, etc.) and renewal of MAH...
business including but not limited to Marketing Authorization Holder (MAH) licences for Pharmaceuticals, Medical Devices...
business including but not limited to Marketing Authorization Holder (MAH) licences for Pharmaceuticals, Medical Devices...
資料への翻訳・編集 PMDAへのMF申請対応 MAHとの調整業務 PMDAとのコミュニケーション(日英対応) 外国製造業者認定関連業務 日本薬事規制に関するレギュラトリーインテリジェンス提供 国内...
. o Participation in periodic Product Quality Review in accordance with the MAH responsibility when required. o Establish...
initiatives. Escalate significant issues to Head of Quality and MAH Director about Medical Device/IVD products Safety process...
knowledge about QMS based on ISO13485 Experiences as Domestic Quality Assurance Manager role and/or So-Kats role in MAH...
global quality policies, and MAH (Marketing Authorization Holder) requirements. The role safeguards business continuity... for Japan commercial operations. 2) MAH and Regulatory Accountability Ensure compliance with all legal obligations under the...