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日志


11月22日

RESPONSIBILITIES

Microbiological: -Microbiological analysis of raw materials and finished products. -Bioassay of antibiotics for regular purposes and to develop methods for the analysis of other antibiotics. -Maintenance of microbial stock cultures from ATCC. -Preservation of different ATCC cultures. - Microbiological analysis of stability products and delivered the records to the proper authority. -Stability study (Microbiological) of preliminary established formulation at 250C ± 20C & 60% ± 5 % RH and 400C ± 20C & 75% ± 5 %C to determine tentative expiry date of the product. -Microbiological Method validation and Growth promotion test of different culture media. -Microbiological Method development and Documentation. -Calibration and validation of different instrument used in microbiology laboratory. -Training of the new employee. -Procuring laboratory supplies. -Maintaining liaison with supplies and service providers to ensure service quality. -Maintaining of good microbiological laboratory practice. Chemical: Raw material, In process, finished products and Packaging Materials: -Routine chemical analysis of raw materials and new source raw materials. -Routine chemical analysis of finished products. -Routine analysis of Packaging materials. -Analysis of stability products and delivered the records to the proper authority. -Stability study (Chemical) of preliminary established formulation at 250C ± 20C & 60% ± 5 % RH and 400C ± 20C & 75% ± 5 %C to determine tentative expiry date of the product. -Able to analysis and to develop method of analysis for finished sample to determine active ingredient and raw material by HPLC and UV spectrophotometer and active ingredient identification by using IR spectrophotometer. -Calibration and validation of different instrument used in Quality Control laboratory. -Preparation review and training of SOPs. -Planning of work for more efficient use of resources. Sampling: Sampling of raw and Packaging materials, Finished products for routine chemical and microbiological analysis And -Any other relevant duties as agreed from time to time with Manager, Quality Control. Instrumental Skill: Adept at operating and calibrating the following apparatus: -HPLC (High performance liquid chromatography) Isocratic & Binary gradient, for bulk and finished drug analysis -IR Spectrophotometer, for Identification and analysis of bulk drug and chemicals [FT IR] -Aerosizer, for particle size determination of finished and bulk drugs -Dissolution & Disintegration apparatus -Single stage Impactor, for the determination of deposition of the emitted dose of Inhalation Aerosol -Potentometric titrator, for finished and bulk drug analysis -Karl Fischer, for water content determination -UV-Visible Spectrophotometer, for finished and bulk drug analysis -Polarimeter for the determination of Optical activity of Bulk Drug -Calibration of UV-visible spectrophotometer, IR spectrophotometer, HPLC pump and UV-visible detector of HPLC system

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