SIBAJYOTI MUKHERJEE

Clinical Research Associate 1 at Raptim Research Pvt. Ltd.
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Contact Information
us****@****om
(386) 825-5501
Location
Navi Mumbai, Maharashtra, India, IN

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Clinical Research Associate 1
      • Sep 2022 - Present

    • India
    • Hospitals and Health Care
    • 1 - 100 Employee
      • Feb 2022 - Aug 2022

      Involved in preparation of startup documentation along with other doc's required during the trial and at the time of Site closeout, daily site activity tracking, site monitoring, assisting the CRA in operational activities, Site Initiation Visit and study tracking activities and coordinating with the CRC and onsite people.

      • Aug 2021 - Jan 2022

      Generic CTA profile, preparation of involved startup documentation along with other doc's required during the trial and at the time of Site closeout, assisting the CRA with day to day activities, Site Initiation Visit and study tracking activities and coordinating with the CRC and onsite people.

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Trainee QA Officer
      • Dec 2020 - Jul 2021

      Handled QMS activities inclusive of Change controls, deviations, CAPA, market complaints, ADR reports and Medical enquires. Handling of GMP documents, BMR handling for manufacturing related inquiries, preparation of Market complaint reports, initiating on site analytical tests for handling of complaints, process research mapping, preparation of monthly, half yearly and yearly management review meetings, Quarterly QMS trends and Quarterly quality metrics. Handled QMS activities inclusive of Change controls, deviations, CAPA, market complaints, ADR reports and Medical enquires. Handling of GMP documents, BMR handling for manufacturing related inquiries, preparation of Market complaint reports, initiating on site analytical tests for handling of complaints, process research mapping, preparation of monthly, half yearly and yearly management review meetings, Quarterly QMS trends and Quarterly quality metrics.

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Research And Development Intern
      • Sep 2020 - Nov 2020

      Had a hands on experience at different analytical instruments utilised in the Quality control and ARD departments in the Pharmaceutical Industry. Had a hands on experience at different analytical instruments utilised in the Quality control and ARD departments in the Pharmaceutical Industry.

    • Consumer Goods
    • 700 & Above Employee
    • Summer Intern
      • Jul 2017 - Jul 2017

Education

  • Birla Institute of Technology, Mesra
    Master of Pharmaceutical Technology, Pharmaceutical Quality Assurance
    2018 - 2020
  • Dr. B. C. Roy College of Pharmacy and Allied Health Sciences 189
    B.Pharma, Pharmacy, Pharmaceutical Sciences, and Administration
    2014 - 2018

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