Saikiran Yewatkar

Experience

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  Fresenius Kabi

  Aug 2018 - Feb 2020

  ● Sterility Testing of Finish & Stability Product (Large Volume Parenterals like IV soltions, Injections, Infusions) by Membrane Filtration.● Execution of Media Preparation section including daily requirement and usage upto its destruction.● Bioburden Testing of Finish product ,Raw Material and Packing Materials.● Trained on Biolog Identification System.● Environment Monitoring of Classified Area by Settle Plate, Active Air and Surface Monitoring.● Non Viable Particle Monitoring of Classified Area● Involve in Autoclave Validation● Involve in Process Validation● Involve in Cleaning Validation Show less

  • Quality Control Supervisor

    Aug 2019 - Feb 2020

  • Post Graduate Trainee

    Dec 2018 - Aug 2019

  • Apprentince Trainee

    Aug 2018 - Nov 2018
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  Glenmark Pharmaceuticals

  Feb 2020 - Jul 2021

  QC Officer(Microbiology)

  ● Microbial Limit Test for Finished/Semi-finished/Stability Product (Aerosol(MDI&DPI)/Foam/API/Oncological oral solids)● Water Testing (WFI/PSC/Purified/Potable/Drinking Water) including Test for Specified Microorganisms● Antimicrobial Effectiveness Testing.● Bacterial Endotoxin Test for WFI and PSC● Environment Monitoring of Classified Area● Identification of Microorganisms By BBL Crystal Mind Method● Preparation and Maintenance of Inhouse Library with regard of Objectionable Microorganisms.● Conducting Analyst Qualification For Newly Joined Candidate.● Revival of Procured Standard Microbial Culture and Cryovial Preparation.● Total Viable Count of Culture Suspension.● Biological Indicator Qualification.● Calibration of Microbiology Laboratory Equipment.●Preparation of Water and Environment Monitoring Trend.● Preparation of Monthly Training reports.● Responsible for Maintaining ATR in Lab.● Three Phase Validation of Water System for New Facility● Area Qualification for New Facility Show less

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  Lupin Pharmaceuticals

  Jul 2021 - Dec 2023

  QC Officer(Microbiology)

  ● Microbial Limit Test for Finished/In-process/ Stability Product (Tablet/Capsule/Oral Suspensions).● Method Suitability Test (MLT Method Validation).● Preparation of Validation Report.● Autoclave Validation● Responsible for Planning and Execution of Media Section and Culture Maintanence.● Identification of Microorganisms By Vitek 2 Compact system.● Bioball Qualification(Count confirmation and Identification).● Swab Sampling and Analysis for Cleaning Validation● Conducting Analyst Qualification For Newly Joined Candidate.● Responsible for Maintaining ATR in Lab.● Three Phase Validation of Water System for New Facility● Area Qualification for New Facility● Preparation of EM and Water trends through Minitab software Show less

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  SUN PHARMA

  Dec 2023 - now

  QC Executive (Microbiology)

  ● Looking after Culture related activities.● Preparation of Study protocols related to Media and Culture.● Instrument/ Equipment Qualification/Validation.● Review of Media section related document.● Preparation of IQO response.● Supporting in QMS activities.