Prepare registration dossier for new product, renewal, extension as well as exported products & products belong to projects on time.
Prepare variation dossier to support alternative supplier development program (chương trình phát triển nhà cung cấp nguyên liệu).
Manage and improve documentation processes, storage, and safekeeping in the factory. Drive compliance to Good Documentation Practices (GDP) in the factory. Ensure that all documents are accurate, up-to-date, and truthful at all times.
Ensure compliance to GMP, PIC/s requirements in the performance of assigned tasks.
Performs other duties and responsibility as may be assigned from time to time.
University graduate, major in pharmacy, chemistry or other related sciences.
Experience in registration dossier at pharmaceutical companies.
English: able to read and understand technical documents.