QA ACTD Team Leader - Trưởng nhóm QA phụ trách hồ sơ đăng ký (Work Location: VSIP 2 - Binh Duong)United Pharma Viet Nam

Mô tả Công việc
Prepare ACTD registration for new product, renewal, extension as well as exported products & products belong to projects on time.
Coordinate with other departments to prepare technical dossiers to submit to MOH/ DAV and export regulatory agencies.
Coordinate with Regulatory Affairs department to communicate with MOH/ DAV to know & understand new regulations.
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.
Work Location: Khu công nghiệp VSIP 2 - Bình Dương