文件和偏差主管

Responsible for managing deviations, changes, and CAPA in the workshop, training personnel, and tracking implementation. Also responsible for managing files and records, ensuring safety, secrecy, and validity.

Requirements

• Familiar with GMP requirements for large molecule biological product workshops
• 8 years or more of GMP file or site management related work experience in the pharmaceutical industry
• Familiar with domestic and foreign GMP laws and regulations
• Familiar with GMP quality system and file system, deviation, and change handling
• Good English listening, speaking, reading, and writing skills