[Factory 1] QC Team Leader (Microbiology group)

Lead and supervise daily QC Microbiology activities, including microbiological testing, sampling and result review.
Oversee Environmental Monitoring, water monitoring, sterility, bioburden, microbial limit testing, stability testing and Media Fill.
Review microbiological data, evaluate trends and provide technical assessment of abnormal/excursion results.
Lead/support investigations related to OOS/OOT, deviation, EM excursion, contamination events and CAPA.
Provide technical support for microbiological method validation/verification, qualification and troubleshooting.
Ensure compliance with GMP, pharmacopoeia requirements and approved SOPs/protocols.
Manage team workload, training, competency assessment and personnel development.
Review, revise and develop microbiological SOPs, protocols, reports and related GMP documents.
Coordinate microbiology laboratory equipment, materials, calibration and maintenance.
Support audits, regulatory inspections and continuous improvement activities.
Collaborate with QA, Production, Engineering, Validation and other departments on microbiological and contamination-control activities.
Perform other duties assigned by QC Manager.