Kathan Rawal

Microbiologist at Aved
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Location
CA

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Experience

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Microbiologist
      • Mar 2023 - Present
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Microbiologist
      • Feb 2021 - Feb 2023
    • Canada
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Control Microbiologist
      • Jan 2020 - Feb 2021
    • Executive
      • Sep 2015 - Sep 2018

      • Led all BET testing of finished products, raw materials and method validation for a variety of drugs including high-priority products like ranibizumab and filgrastim • Conducted closed method sterility testing of daily filled batches, finished products and packaging materials along with method validation for new drugs like rituximab • Utilized Beckman Coulter instruments to conduct a liquid-borne particle count test (10 and 25 micron) of finished products and R&D samples • Prepared and compiled all trend reports on a monthly and yearly basis • Conducted bioburden and MLT for raw materials and finished products utilizing the liquid filtration method • Responsible for environmental monitoring procedures and maintaining the integrity of sterile rooms through cGMP like settle plate, air sampling, personnel monitoring, surface monitoring and air particle counter testing • Responsible for the preparation of QMS-related documents including Study Protocols, Study Reports, SOPs, OOS Investigation Report and others as required Show less

    • Technician
      • Jan 2015 - Sep 2015

      • Performed BET testing for medroxy progesterone including raw materials and finished goods along with its method validation • Conducted MLT for solid oral doses and utilized liquid filtration processes in the testing of water for injection • Monitored sterile rooms through settle plate, air sampling, personnel monitoring, surface monitoring and air particle counter testing to ensure cGMP • Responsible for validating and qualifying (IQ, OQ and PQ) new software and instruments like liquid-borne particle and total organic carbon counters • Led system suitability testing which included TOC and its operation to ensure suitable quality for samples • Responsible for calibration of critical testing instruments like physical balances, pH meters and conductivity meters Show less

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Technical Trainee
      • May 2013 - Jan 2015

      • Performed open and closed method sterility testing of dry powder injection cephalosporin products and its packaging • Tested finished products and R&D samples using a liquid-borne particle counter (10 and 25 micron) • Performed temperature monitoring and mapping by using Neutronics tools in incubators to ensure processes were aligned with cGMP • Operated Pharmalab autoclaves to sterilize garments, media, and tools used in quality control processes • Conducted settle plate, air sampling, personnel monitoring, surface monitoring and air particle counter testing to ensure non-sterile and sterile rooms met cGMP standards • Led environmental monitoring and observed aseptic fill processes related to dry powder injections at intervals set by regulatory guidelines • Performed preparation, sterilization, incubation and growth promotion testing of routine media Show less

Education

  • Sikkim Manipal University - Distance Education
    Master of Business Administration - MBA, Total Quality Assurance
    2013 - 2015
  • Sardar Patel University
    Master's degree, Biotechnology
    2008 - 2013
  • Sardar Patel University
    Bachelor of Science - BS, Biotechnology
    2008 - 2011

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