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.
You will contribute by assisting in building the factory's quality management system, completing production and analytical method validation with the team, and ensuring new product production lines pass the regulatory authority's on-site inspection for market approval.
You are the right candidate if you have a Bachelor's degree or above in pharmaceutical, pharmacy, or chemistry-related fields, with 3+ years of QA experience in the pharmaceutical industry, and good GMP knowledge.
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
China GMP compliance
quality management system
production and inspection
SOP revision and optimization
regulatory compliance
Nice-to-have
continuous improvement
cross-functional collaboration
proactive problem-solving
strong communication skills
Key Requirements
Bachelor's degree or above in pharmaceutical, pharmacy, or chemistry-related fields
3+ years of QA experience in the pharmaceutical industry
Experience with ANDA registration on-site inspection and GMP compliance inspection preferred
Familiarity with GMP knowledge and pharmaceutical regulations
Experience dealing with regulatory authority on-site inspections and external communication