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(PV) system, fulfilling the duties of a Marketing Authorization Holder (MAH). Ensure compliance with local...
一緒ã«åƒãã¾ã—ょã†ã€‚ 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...
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. 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...