Manager-track GQP quality assurance for Nippon Kayaku's pharmaceuticals: data review for manufacturing sites in Japan and overseas, audits, regulatory filings and developing junior staff.
About this role
A quality assurance role in the department responsible for GQP (Good Quality Practice) work across all pharmaceutical products Nippon Kayaku markets as marketing authorization holder.
The work covers pharmaceutical quality assurance: checking data from domestic and overseas manufacturing sites, risk management and audits. It also includes compliance with the GQP, GMP and QMS ministerial ordinances, such as maintaining procedures, inspecting documents and QC tasks, and regulatory affairs work such as partial-change applications for marketing approvals and preparing PMDA consultation materials. Over time the person is expected to learn all GQP work and team management, as a future candidate for quality assurance manager and for manufacturing manager at the Takasaki plant.
Requirements: a university degree, hands-on GQP/GMP quality assurance experience (for example auditing drug manufacturing sites), and a pharmacist licence.
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