Ajay Bosamiya, (M.Pharm)
Freelance Auditor
Ajay Bosamiya, M.Pharm
Freelance Auditor
B-12 Neel-Deep Avenue,
Bodakdev, Ahmedabad
E-mail: freelancerajay248@gmail.com
Phone: +919409489904
+919664634524
CV
Professional info
Quality Assurance Auditor having 6.5 years of experience in Quality Assurance, Bioanalysis and Anaytical development interested to work in Quality Assurance aspects of Pharmaceutical sciences to serve the sector better and further learn to serve better.
Work experience (6.5 Years)
Bioanalytical Quality Assurance (2 Years)
Feb 2016-Present
Position :
Associate Scientist E3 Grade (Quality Assurance-Bioanalysis)
Job profile:
To Perform…
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Study specific audit (in-process and reterospective audit).
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Method validation audit (in-process and reterospective audit).
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System audit, vendor audit and site audit.
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Method SOP, Method validation plan, method book and bioanalytical study plan review.
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Calibration data of instruments like HPLC, MSMS, Analytical Balance, Micro Pipettes.
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Project report, eCTD and Method validation report review.
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SOP preparation and review.
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Review of change control form.
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Review of response to regulatory and sposor’s observations.
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Hosting clients audits.
Analytical Development Research (2 Years)
From March 2014 to Feb 2016
Position :
Scientist (Bioanalytical)
Job profile:
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To carry out Method development and validation for the analysis of drug in human plasma by LCMSMS
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To carry out the study sample analysis of drug in human plasma by LCMSMS
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To ensure adherence to work systems, GLP compliance and effective reporting of method development work
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Responsible for Calibration and Maintenances of sophisticated instruments like LCMSMS, Analytical Balance, Micro Pipettes and pH meter etc.
Bioanalytical Development Research (2.5 Years)
From Sep 2011 to Feb 2014
Position :
Scientist (Bioanalytical)
Job profile:
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To carry out Method development and validation for the analysis of drug in human plasma by LCMSMS
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To carry out the study sample analysis of drug in human plasma by LCMSMS
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To ensure adherence to work systems, GLP compliance and effective reporting of method development work
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Responsible for Calibration and Maintenances of sophisticated instruments like LCMSMS, Analytical Balance, Micro Pipettes and pH meter etc.
ACADEMIC EXPERIENCE
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Done a project titled “Attempts to improve bioavailability of Nicardipine hydrochloride by solubility and permeability enhancement” (M.Pharm. Part-II Project)
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In situ intestinal perfusion study in rats
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In vitro solubility study
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Analytical method development and validation and its application to solubility sample analysis
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Bioanalytical method development and validation and its application to in vivo pharmacokinetic study in rats
Skills
Microsoft outlook
Microsoft Excel
Microsoft Word
Microsoft Powerpoint