Design injectable formulations for anticancer drugs and biosimilars, from formulation and process studies to scale-up, CTD preparation for approval filings and CMC development support.
About this role
A manager-candidate 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 includes compliance with the GQP, GMP and QMS ministerial ordinances (maintaining procedures, inspecting documents, QC tasks), regulatory affairs work such as partial-change applications for marketing approvals and PMDA consultation materials, and developing junior and mid-level staff. The person is expected to master 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 and hands-on GQP/GMP quality assurance experience, for example auditing drug manufacturing sites.
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