Manish Kumar
Assistant Manager ( ARL Department ) at iTrace Pharmaceutical Solutions Private Limited- Claim this Profile
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Experience
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iTrace Pharmaceutical Solutions Private Limited
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Assistant Manager ( ARL Department )
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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.
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GVS Cibatech Pvt Ltd
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Executive ( ARL Department )
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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 ).
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Geochem Laboratories Private Limited (Mumbai)
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India
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Biotechnology Research
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1 - 100 Employee
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Junior Analyst
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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.
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Education
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Mumbai University Mumbai
Master of Science - MS