Regulatory Site Officer
Pharmaceutical/Medical
Ho Chi Minh
Negotiable
• Preparing Registration Dossiers (Technical Part) for new product, product with expired visa number, product with changes • Updating or modifying the Site Master File • Managing the application of the registration dossier to the Production and QC activities, ensuring the compliance. • Defining the new requirements in terms of technical dossiers for each item or group of product in case of a new registration regulation, or of a new VN Pharmacopoeia. • Controlling of the transfer document when technique handover. • Check the text of the new packaging material artworks according to the approved registration ones. • Update data requested by the IRCC Compliance Operations Management e-Room • Participate and support in HSE activities in plant
• University graduated in Pharmacy or Biology • 2- years experience in pharmaceutical production and quality control • Intermediate English skill
Please submit your updated CV to hong.nguyen@talentviet.com & nga.vo@talentviet.com; directly contact Ms. Hong Nguyen at 3910 1126 - ext 106 for more information.