Amrendra Kumar Email & Phone Number

India

Microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile & sterile dosage forms.BET testing of WFIMicrobial test of water sample (WFI & Purified water)Environnement monitoring of Microbiology Lab and manufacturing area.Trend preparation of Environmental monitoring data & water analysis data.Maintenance of reference cultures used in Microbiology Lab.Calibration of instruments of Microbiology Lab.Autoclave validationMLT… Show more Microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile & sterile dosage forms.BET testing of WFIMicrobial test of water sample (WFI & Purified water)Environnement monitoring of Microbiology Lab and manufacturing area.Trend preparation of Environmental monitoring data & water analysis data.Maintenance of reference cultures used in Microbiology Lab.Calibration of instruments of Microbiology Lab.Autoclave validationMLT validationAntimicrobial effectiveness testingDisinfectant validationWater validationSampling devices cleaning validationGarment cleaning & hold time validationClean & Dirty equipment hold time study Area mapping for environmental monitoring Show less

Handling of Microbiology Laboratory functions independently.Handling of audits and their compliance independently.Planning and execution microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile oral dosage forms.Preparation and execution of protocols and reports for validation of Autoclave, Water, HVAC, MLT etc.Management of analysis of Process validation samples & Swab samples.Environnement monitoring of Microbiology Lab and… Show more Handling of Microbiology Laboratory functions independently.Handling of audits and their compliance independently.Planning and execution microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile oral dosage forms.Preparation and execution of protocols and reports for validation of Autoclave, Water, HVAC, MLT etc.Management of analysis of Process validation samples & Swab samples.Environnement monitoring of Microbiology Lab and manufacturing area.Daily Work allotment to the subordinates.Preparation of SOP’s, STP’s and specifications for Water/Raw- Material/Finished goods.Maintenance of reference cultures used in Microbiology Lab.Calibration of instruments of Microbiology Lab.Training & Guidance to analyst and their qualification as per schedule.QC & Microbiology indent created through SAP software. Show less

Microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile & sterile dosage forms.BET testing of WFIMicrobial test of water sample (WFI & Purified water)Environnement monitoring of Microbiology Lab and manufacturing area.Trend preparation of Environmental monitoring data & water analysis data.Maintenance of reference cultures used in Microbiology Lab.Calibration of instruments of Microbiology Lab.Release through LIMS software.

Microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile & sterile dosage forms.Sampling of sterile product.Sterility testing (open method)BET testing of sterile product (Bulk, FG stage, WFI, PW )Microbial test of water sample (WFI & Purified water)Environnement monitoring of Microbiology Lab and manufacturing area.Trend preparation of Environmental monitoring data & water analysis data.Maintenance of reference cultures used in… Show more Microbiological analysis of Water/Raw- Material/In-Process/Finished Goods samples of non-sterile & sterile dosage forms.Sampling of sterile product.Sterility testing (open method)BET testing of sterile product (Bulk, FG stage, WFI, PW )Microbial test of water sample (WFI & Purified water)Environnement monitoring of Microbiology Lab and manufacturing area.Trend preparation of Environmental monitoring data & water analysis data.Maintenance of reference cultures used in Microbiology Lab.Calibration of instruments of Microbiology Lab. Show less