Lead the local implementation and operational excellence of AZ eQMS in China, covering document control, training, change control, deviations, and CAPA
Job Summary
Lead the local implementation and operational excellence of AZ eQMS in China, covering document control, training, change control, deviations, and CAPA.
Ensure quality systems are fit-for-purpose, compliant with applicable regulations (China GMP, US FDA, EU GMP, PIC/S, ICH Q9/Q10, ATMP) and support regulatory inspection readiness.
Develop and execute risk-based training programs to ensure personnel understand and comply with GMP requirements, AZ QCM, and cell therapy-specific quality practices.
Matching Summary
Lead the local implementation and operational excellence of AZ eQMS in China, covering document control, training, change control, deviations, and CAPA.
Skills & Requirements
Must-have
AZ eQMS implementation
document control
training management
change control
deviation management
CAPA management
China GMP compliance
Nice-to-have
cross-functional collaboration
continuous improvement
risk-based training
data integrity ALCOA+
Key Requirements
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
5+ years of experience in robust GMP quality system