Microbiological inspector (GMP Hong Kong)

Job Responsibilities

1. Microbiological testing: Strictly follow the pharmacopoeia and operating procedures, and be responsible for the detection of microbial limits, sterility, bacterial endotoxin, etc. of raw materials, packaging materials, finished products, and process water.

2. Laboratory material management: Responsible for the preparation of culture media, sensitivity testing, and the transfer, preservation, and use record management of experimental bacterial strains.

3. Methodology and quality control: Participate in the validation of microbial testing methods, responsible for the preliminary investigation and reporting of OOS (out-of-specification) results during the experiment.

4. Environmental monitoring: According to the plan, air suspended particles, settling bacteria, floating bacteria and surface microorganisms are monitored and sampled in the production clean zone (including aseptic production area).

5. Record and report: Accurately record the experimental process and results, and promptly issue standardized test reports.

Position requirements

1. Education and major: Bachelor's degree or above, Pharmacy, Microbiology, Biotechnology or related fields.

2. Work experience: More than 3 years of GMP pharmaceutical factory QC work experience, of which at least 1 year is dedicated to pharmaceutical microbiological testing.

3. Professional knowledge: Familiar with the Chinese Pharmacopoeia, European Pharmacopoeia or United States Pharmacopoeia's aseptic and microbial limit test methods, and familiar with aseptic operations and basic knowledge of microbial identification.

4. Requirements: Priority will be given to those with sterile operation-related training certificates.

5. Professional ethics: Have a high level of aseptic awareness and responsibility, work meticulously, and be able to strictly follow laboratory biosafety guidelines.