M&s-head Of Quality Assurance Operation Unit (apu) & Sterility-beijing
Sanofi
Beijing, China
5+ years qa or qc experience
3+ years management position
3+ years sterility assurance experience
The role involves leading the Quality Assurance operation unit to ensure product manufacturing and control under cGMP conditions while aligning with global and local regulatory standards
Job Summary
The role involves leading the Quality Assurance operation unit to ensure product manufacturing and control under cGMP conditions while aligning with global and local regulatory standards.
As a key expert in sterility assurance, the incumbent will establish robust contamination control strategies and provide technical proposals for clean zone reconstruction and process optimization.
The position requires managing a QA team, overseeing CAPA implementation, and ensuring continuous GMP training to maintain high compliance levels across production, laboratory, and warehouse operations.
Matching Summary
The role involves leading the Quality Assurance operation unit to ensure product manufacturing and control under cGMP conditions while aligning with global and local regulatory standards.
Skills & Requirements
Must-have
5+ years QA or QC experience
3+ years management position
3+ years sterility assurance experience
Knowledge of cGMP and regulatory requirements
Microbiology and analytical chemistry knowledge
Bachelor degree in pharmacy, chemistry, or biology
Nice-to-have
Strategic thinking capabilities
Strong leadership and communication skills
Ability to handle high pressure situations
Experience with medical device GSP regulations
Fluency in English verbal and written
Key Requirements
Minimum 5 years experience in quality control or assurance
At least 3 years in a management role
3+ years specific experience in sterility assurance
Bachelor's degree in pharmacy, chemistry, biology, or related field