- 1.Temperature, RH and Differential pressure monitoring of Microbiology Lab areas and refrigerator.
- 2.Microbial limit test, Pathogen and Bio-burden test of Raw material, Finished product as per current version of Specification and STP
- 3.Sampling of water
- 4.Chemical and Microbial Analysis of Raw, Purified, ETP and drinking water.
- 5.Environmental monitoring by settle plate method
- 6.Observation of MLT and Environmental monitoring of plates
- 7.Calibration and maintenance of microbiology laboratory instruments
- 8.Management of culture and sub-culture
- 9.Management of media reconciliation and Growth Promotion Test
- 10.Media preparation and sterilization
- 11.Management of sample during microbiological analysis
- 12.Preparation of recent SOPs and periodic review of SOPs of Microbiology-
QC
- 13.Maintaining all microbiological records and logbook
- 14.Bacterial Endotoxin test,
TOC and pH conductivity
- 15.Microbial Assay, Bacterial Endotoxin test, Sterility analysis
- 16.Microbial Assay, Bacterial Endotoxin test, TOC and pH conductivity
- 17.Reporting of any OOS parameter during EM, MLT or sterility testing.
- 18.Training of microbiologist.
- 19.Review of Microbiology raw data & reports.
- 20.Involve in investigation related to any failure with respect to microbiology.
- 21.Review of microbial trends.
- 22.Preparation/review of Standard Operating procedures for microbiology Laboratory functions.
- 23.Monitoring and Review of personnel monitoring.
- 24.Monitoring and Review of all Microbiology procedures and activity
- 25.Monitoring and Review of Analyst Qualification Procedure