Lead the entire process of microbiological testing for raw materials and finished products to ensure timely and accurate test results that meet product manufacturing and release standards.
Strictly implement the company's safety policies, GMP/GLP standards and SMP/SOP procedures to ensure that laboratory operations comply with cleanliness and management requirements.
Participate in the development, confirmation and validation of routine testing methods for raw materials, auxiliary materials and finished products entering the factory, and optimize the testing technology system.
Be responsible for the monitoring of clean environments and microbial detection work, and provide technical guidance and operation training for team members.
Independently carry out core testing items such as sterility tests, bacterial endotoxin detection (BET), and microbial limit tests to ensure reliable data.
Assist superiors in conducting investigations into microbial-related deviations, provide technical support during the filling process, and formulate and implement corrective and preventive actions (CAPA).
Participate in the daily management and maintenance of laboratory strains, culture media, reagents and equipment, and promote resource optimization and process improvement.
Cooperate to complete the responses to changes and audit findings and the execution of action items, and participate in the drafting and revision of microbiology laboratory documents (SMP/SOP/Form).
Assist internal and external auditing work and ensure compliance.