The QC Team Leader for the Microbiology Department is responsible for overseeing and ensuring the accuracy and efficiency of microbiological testing and validation processes. This role involves managing the microbiology team, ensuring compliance with regulatory standards, and maintaining the quality and safety of products through rigorous testing and monitoring.
Responsibilities:
- Understand, implement, and check the work of the microbiology department:
• Sample testing by microbiological methods: Sterility test, bacterial contamination test, bacterial identification isolation, antibiotic potency quantification, endotoxin determination
• Validation of microbiological testing methods, evaluate the suitability of the method.
• Monitor the microbiological limits of the production environment and production equipment
• Manage chemicals, standards, microbial strains, tools, and equipment of the Microbiology department
• Prepare the specification, method for raw materials and excipients, updated according to the current pharmacopeia version.
• Prepare testing records according to regulations
• Troubleshooting during routine sample analysis
• Manage the microbiology room
• Set up analytical records according to ACTD, GLP, ISO
- Manage risk assessment to prevent incidents from occurring and improve the system.
- Every week, report to QC Manager on the situation and results of assigned work.
- Perform other tasks assigned by QC Manager.
