MÔ TẢ CÔNG VIỆC:
- 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.
YÊU CẦU CÔNG VIỆC:
- 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.
THÔNG :
Probation: 2 months of probation with full salary
Working time: 44 hours/week
Training:
A2E skill training
Pre-mortems
Prioritization
Problem-solving
Owner's mindset
Idea generation
Coaching
Influencing
Courageous conversations
Effective communication
Presenting with impact
Closed-loop conversations
Creating business value
Effective meetings
Effective emailing
Organizational health
Colleagues: Friendly & Supportive
Annual Leave:
- 15 working days: from full 1 year to less than 3 years;
- 16 working days: from full 3 years to less than 7 years;
- 22 working days: from full 7 years or more to less than 37 years.
Benefits:
Personal Health Insurance for Staffs over 2 years contribution
Company trip, Team building activities
Holiday events
Other Allowances:
Company bus from HCMC to Factory
Parking fee