Manish Kumar

Assistant Manager ( ARL Department ) at iTrace Pharmaceutical Solutions Private Limited
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Location
Mumbai, Maharashtra, India, IN

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Assistant Manager ( ARL Department )
      • Apr 2021 - Present

      Nitrosamine, NDSRI Related impurity method development as well as method validation. Extractable and Lechable studies. Nitrosamine, NDSRI Related impurity method development as well as method validation. Extractable and Lechable studies.

    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Executive ( ARL Department )
      • Dec 2020 - Apr 2021

      Extractable And Leachable Studies. method development, method validation activity as well as Routine analysis. Nitrosamine analysis. maintenance, calibration and trouble shooting of LC-MS/MS and HPLC. pH calibration, Balance calibration ( daily and monthly ). Extractable And Leachable Studies. method development, method validation activity as well as Routine analysis. Nitrosamine analysis. maintenance, calibration and trouble shooting of LC-MS/MS and HPLC. pH calibration, Balance calibration ( daily and monthly ).

    • India
    • Biotechnology Research
    • 1 - 100 Employee
    • Junior Analyst
      • Oct 2015 - Oct 2020

      Performed analysis on sample food and enviornment related product. Hand an experience and technical expertise in multiple analytical technique LC-MS/MS TQQQ 6410,64640,6470 And HPLC agilent software mass hunter. Execution of Method transfer and Method validation. performed maintenance and calibration and trouble shooting of LC-MS/MS and HPLC. participation in regulatory audits EIC, NABL FSSAI etc. followed proper documentation practice as per SOP, ISO 17025 guideline. Performed analysis on sample food and enviornment related product. Hand an experience and technical expertise in multiple analytical technique LC-MS/MS TQQQ 6410,64640,6470 And HPLC agilent software mass hunter. Execution of Method transfer and Method validation. performed maintenance and calibration and trouble shooting of LC-MS/MS and HPLC. participation in regulatory audits EIC, NABL FSSAI etc. followed proper documentation practice as per SOP, ISO 17025 guideline.

Education

  • Mumbai University Mumbai
    Master of Science - MS

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