S Baskar Email & Phone Number

To perform Environment monitoring in clean areas (Aseptic area)by following respective area entry exit procedure and preparation ofits trends, drain monitoring, Nitrogen gas and compressed gasmonitoring by following respective SOP. line clearance and aseptic area review in filling area . To perform bioburden and swab filtration by using the MILLIFLEXOASIS system. To perform Bacterial Endotoxin Test of in process water samples. To perform biological indicator recovery as per SOP, Activelyparticipated in Validation of Aseptic Process Media fills. Environmental Monitoring. Sterility test by close, open and directinoculation method by using BIOQUELL isolator. Visual inspectionof media fill vials/ampoules Updating all test related data in LIMSand LABWARE software. Perform QC evaluation on data feed in LIMS and LABWARE. Preparation and review of SOPs, Protocols, Reports, COA’s, Trendsdata and summary report. Informing the laboratory head/sectionhead about OOS, OOT and deviation if any during the analysisthrough TRACKWISE software. Experience in extracting, creating data sets from various source likeExcel and LIMS and LABWARE software ENM Summary completion in LIMS ,Batch release ENM reportpreparation . MLT analysis (Raw material, In process, Finished product, stability)Culture maintenance and sub culture and culture suspensionpreparation,GPT in media . Reconciliation of media ,water sampling and analysis . isolation and identification of Microorganisms by Vitek MS system. Sterility test by close, open and direct inoculation method by usingBIOQUELL isolator.