This position is primarily responsible for ensuring all drug production, inspection, and release activities strictly comply with China GMP and the company's internal quality management system requirements to ensure product quality and patient safety
Job Summary
This position is primarily responsible for ensuring all drug production, inspection, and release activities strictly comply with China GMP and the company's internal quality management system requirements to ensure product quality and patient safety.
Assist in building the factory's quality management system, and work with the team to complete the validation of production and analytical methods, ensuring that the new product production line passes the on-site inspection for market authorization by the drug regulatory authority.
Identify gaps and improvement opportunities in existing processes before market authorization application, and lead the revision of relevant SOPs to continuously optimize and maintain the quality management system.
Matching Summary
This position is primarily responsible for ensuring all drug production, inspection, and release activities strictly comply with China GMP and the company's internal quality management system requirements to ensure product quality and patient safety.
Skills & Requirements
Must-have
GMP compliance
quality management system
SOP revision
production site supervision
audit support
Nice-to-have
continuous optimization
proactive problem solving
cross-functional collaboration
Key Requirements
Bachelor's degree or above in Pharmacy, Pharmaceutical Sciences, or Chemistry
3+ years of QA experience in the pharmaceutical industry
Experience with ANDA registration on-site inspections and GMP compliance inspections is preferred
Familiarity with GMP knowledge and relevant laws and regulations