[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.

• Bachelor's degree or above in Microbiology, Biotechnology, Biology, Pharmacy or related fields.

• 3–5 years of experience in Pharmaceutical QC Microbiology, preferably in sterile pharmaceutical manufacturing.

• Strong knowledge of Environmental Monitoring, sterility testing, bioburden, microbial limits, water microbiology and Media Fill.

• Knowledge of GMP, USP/Ph. Eur., contamination control, microbiological investigation and CAPA.

• Experience in team leadership, analyst training and competency assessment is preferred.

• Good analytical, problem-solving and communication skills.

• Good English reading and writing skills.

Ngành nghề: Dược phẩm/ Hóa Mỹ Phẩm, Quản lý chất lượng (QA/QC), Sản xuất / Vận hành sản xuất

Kinh nghiệm: 3 Năm

Cấp bậc: Trưởng nhóm / Giám sát

Hình thức: Nhân viên chính thức

Địa điểm: Bình Dương