社名
社名非公開
求められる経験
■Requirements
・Minimum 10 years of experience in a QA role within the pharmaceutical industry.
・Minimum 3 years of experience as a QA Manager or QC Manager for Type I, Type II, or regenerative medical products.
・University degree or higher in a biological science (medicine, pharmacy, science, agriculture, etc.); doctoral degree preferred.
・Expert knowledge of Japanese pharmaceutical regulations (PMDA and MHLW).
・Proven experience conducting GMP audits and supporting regulatory inspections.
・Experience reviewing manufacturing documents, deviations, change controls, and CAPAs.
・Excellent written and verbal communication skills in English and Japanese.
・Proven ability to lead and manage a team.
・Experience preparing presentations and communicating complex information clearly.
・Strong understanding of QMS, SOP development, and vendor management.
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