Experience

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  Cyclone pharmaceuticals pvt ltd

  Aug 2015 - Mar 2017

  Executive gmp and regulatory compliance

  • Drafting of Quality documents.• Upgradation of Quality Documents.• Drafting of SOP.• Specifications, BMR, BPR.• Method of Analysis.• QMS Documents as per requirement of Different Projects.• Implementation for EU and PICS compliant GMP Systems and documentation systems.• Training and Coordination with clients for implementation of QMS• Assisting GMP Auditors for Audit preparation• DMF Compilation in CTD Format• Introductory work for Dossier compilation in CTD Format.• Preparation of Backup Documents for dossier Compilation. Show less

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  Bioclin research llp

  Mar 2017 - May 2018

  Clinical research associate

  • Distribution and Presentation of ICF.• Check In and Check Out Procedure.• Registration and Screening of Volunteers.• Distribution and Supervision of meals.• Plasma Separation and Interim Storage.• Transfer of Sample from CR to BA/Sponsor site.• Review of Data and Compliance.• Supervision of study Activities and clinical Co-ordination.• Receive of Study Related Document from QA• Assisting to medical writer in the preparation of Informed consent form, Protocol preparation, Case report form. Show less

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  Anazeal analyticals & research pvt. ltd

  Sept 2018 - Aug 2019

  Clinical research associate

  • Clinical trial documents like Synopsis, Investigational broacher, Protocol, Informed consent form, case report form, Patient Daily Diary card preparation.• Compilation of DCGI registration and EC submission of file.• Preparation of PSUR report.

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  Unique clinical research

  Aug 2019 - Mar 2021

  Clinical research coordinator

  • Overseeing the smooth running of clinical trial• Collecting, analyzing and coding of data obtained from research.• Information participants about study objective.• Administering questionnaires.• Monitoring research participants to ensure adherence to study rules.• Adhering to research regulatory standards.• Maintaining detailed record of studies as per FDA guidelines including things as per drug dispensation.• Participating in subject recruitment efforts.• Ensuring that the necessary supplies and equipment for a study are in stock & in working order.• Engaging with subjects & understanding their concerns. Show less

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  Paperless gmp by gmp software pvt. ltd.

  Mar 2021 - Jan 2022

  Assistant manager

  • Review of Technical documents. • Review of Technical flow of GMP software.• Handling of Client communication.• Training & Guidance to juniors regarding document preparations.• Handling & Resolving of client Queries etc.