Role & responsibilities
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