microbiologist
mdm
Total des années d'expérience :3 years, 9 Mois
- Performs release testing, including sterility, pH, growth promotion, indicative, and inhibitory testing, of all purchased microbiological culture media .
Isolation, identification & maintenance of Microbial culture. -
- Microbial limit test of In-process, process control samples and Raw materials.
- Water sampling from various sampling testing under the Microbial method. -
Prepare cultures and isolates for microorganisms . -
- Sampling of raw materials, packaging materials, semi-finished products.
- Perform analysis for packaging materials, raw materials, semi-finished product, finished product.
- Perform sterility testing for parenteral preparation ( Direct inoculation membrane filtration method).
- Perform Endotoxin LAL test (Gel - Clot ) for water for injection (WFI), raw materials and finished products.
- Environmental Monitoring in classified areas ( class A, B, C, D ) by settle plate, air sampler, surface sampling, personnel sampling.
- Testing efficacy of disinfectant.
Perform antibiotics - Microbial assay . -
- Gram stain and microscope examination for bacteria .
- Qualification and testing for biological indicator.
Validation of sterilization process using biological indicators.-
- Perform Microbial limit test for non- sterile products.
- Perform microbial water analysis.
- Prepare logbooks template for microbial test ( media quality control, pyrogencity test, bioburden test, LAL test, Total Microbial Count, .... etc. ).
- Maintain good documentation practices.
Perform verification of GMP documents and results.
- Collect environmental samples from the sites and performs environmental analysis. Maintains environmental isolates and identifies environmental isolates from clean rooms.
- Releases products from testing once all criteria are met, as specified in the procedures and testing specifications.
-Performs environmental monitoring of surface bioburden, airborne bioburden, and airborne particles for manufacturing cleanrooms, laminar flow hood/biological safety cabinets, and compressed air .
-Familiar with the following instrumentation: pH and conductivity meter, analytical balances, Air Samplers, hot plate, dispensers, autoclaves, ovens, incubators colony counters, laminair flow, shakers, water bath, memberane filteration millipores and Particle Counter.
- Maintenance of temperature, pressure and humidity records.
-Performs release testing of all purchased ATCC organisms.
- Performs chemical glades for all microbiological dehydrated culture media.
- analyze and interpret results from microscopic examination, Gram stain, acid fast stain, and giemsa staining selective and differential media, biochemical tests, and conduct antimicrobial susceptibility tests.
- Performs blood qc tests and record results in log book.
- Preparation and revision of SOPs whenever required.
- Review analytical reports.
- Maintenance and quality check of Biological indicators.
- Performs release testing, including sterility, pH, growth promotion, indicative, and inhibitory testing, of all purchased microbiological culture media .
Isolation, identification & maintenance of Microbial culture. -
- Microbial limit test of In-process, process control samples and Raw materials.
- Water sampling from various sampling testing under the Microbial method. -
Prepare cultures and isolates for microorganisms . -
- Sampling of raw materials, packaging materials, semi-finished products.
- Perform analysis for packaging materials, raw materials, semi-finished product, finished product.
- Perform sterility testing for parenteral preparation ( Direct inoculation membrane filtration method).
- Perform Endotoxin LAL test (Gel - Clot ) for water for injection (WFI), raw materials and finished products.
- Environmental Monitoring in classified areas ( class A, B, C, D ) by settle plate, air sampler, surface sampling, personnel sampling.
- Testing efficacy of disinfectant.
Perform antibiotics - Microbial assay . -
- Gram stain and microscope examination for bacteria .
- Qualification and testing for biological indicator.
Validation of sterilization process using biological indicators.-
- Perform Microbial limit test for non- sterile products.
- Perform microbial water analysis.
- Prepare logbooks template for microbial test ( media quality control, pyrogencity test, bioburden test, LAL test, Total Microbial Count, .... etc. ).
- Maintain good documentation practices.
Perform verification of GMP documents and results.
- Collect environmental samples from the sites and performs environmental analysis. Maintains environmental isolates and identifies environmental isolates from clean rooms.
- Releases products from testing once all criteria are met, as specified in the procedures and testing specifications.
-Performs environmental monitoring of surface bioburden, airborne bioburden, and airborne particles for manufacturing cleanrooms, laminar flow hood/biological safety cabinets, and compressed air .
-Familiar with the following instrumentation: pH and conductivity meter, analytical balances, Air Samplers, hot plate, dispensers, autoclaves, ovens, incubators colony counters, laminair flow, shakers, water bath, memberane filteration millipores and Particle Counter.
- Maintenance of temperature, pressure and humidity records.
-Performs release testing of all purchased ATCC organisms.
- Performs chemical glades for all microbiological dehydrated culture media.
- analyze and interpret results from microscopic examination, Gram stain, acid fast stain, and giemsa staining selective and differential media, biochemical tests, and conduct antimicrobial susceptibility tests.
- Performs blood qc tests and record results in log book.
- Preparation and revision of SOPs whenever required.
- Review analytical reports.
- Maintenance and quality check of Biological indicators.
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