About this role
• 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.