Implement the laws, regulations, instructions, and directives of the Food and Drug Administration.
Supervise the preparation and approval of the comprehensive product file and the comprehensive production site file based on the latest international guidelines and update them.
Supervise the good principles of GMP and GXP in warehouse production, quality control, guaranteed quality, etc.
Supervise and storage conditions of materials and products and control the expiration date of materials in the warehouse.
Release raw materials and finished products.
Supervise the compilation of records and their final approval.
Supervise and control the quality and authenticity of goods at the supply level (PMS) periodically and submit reports to the Food and Drug Administration.
Complete information related to each process in the TTAC system.
Requirements:
Pharmacist (PharmD).
At least 3 years of experience as a responsible pharmacist (contract manufacturing).
Familiarity with the principles of GXP (GLP, GDP, GSP, GMP, etc.) based on the international GMP guidelines approved by the General Department of Drug and Narcotics Monitoring and Evaluation (such as PIC/S, WHO, etc.).
