Bio-pharmaceutical product quality assurance business
富士フイルムホールディングス株式会社
- GMP
- Bio-pharmaceutical products
- SOP
- GQP
- CMO
- Bio CDMO
- PQR
- EBR
- quality assurance business
- bio-pharmaceutical product quality assurance business
-
Tokyo
-
101 to 1,000
Company Info
Job Summary
In the recruitment position, you will be responsible for the quality assurance (GQP) of bio-pharmaceutical products, support for the Chief Medical Officer (CMO), support for overseas MAH applications, management of document systems, and a wide range of tasks. Practical experience in pharmaceutical GQP and GMP, and the ability to understand basic pharmacovigilance in English are required.Duties
We are looking for someone to be responsible for the quality assurance (GQP) of bio-pharmaceutical products. Specifically, you will be responsible for changes in the Chief Medical Officer (CMO), deviations, and product quality contract and manufacturing instructions, as well as handling of PQR and EBR, and the work at the time of revision of the manufacturing site SOP. In addition, you will also be responsible for supporting the overseas MAH application and document management system. We are also looking for personnel to support the bio-pharmaceutical product quality assurance business of the Bio CDMO business, and detailed records of abilities related to the development and manufacture of bio-pharmaceutical products, as well as expectations, qualifications, and work locations.Login to see all information about offers.
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