Experience

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  Panexcell clinical lab private limited (official)

  Nov 2020 - Jan 2022

  • To ensure the trail is performed & the data are generated, documented & reported in compliance with protocol, SOPs, GCP and applicable regulatory requirements. • To prepare Plan and conduct the in process audit.• In-process Audits of various activities like ICF presentation, Compliance of Check-in, Check-Out, IP recipient activities, IP reconciliation activities, Dispensing activities, Dosing activities, Phlebotomy area Sample separation, Vital signs, Medical Examination, Ambulatory activities etc. During the course of the Clinical Study. • To perform retrospective audit of ICF, MSR, individual CRF, Trial Master File, Raw data files and IMP Documents. • Conduct system audits as per schedule, prepare audit report and ensure compliance. • Sample separate document, scanned CRF, CRF and other relevant project specific documents etc. • SOP preparation and their periodic revision. • To review of Internal & External Calibrations Documents. • Reviews & Checking Clinical Summary Report. • To review of Draft Protocol, ICF and CRF before IEC Approved. • To review draft and final study report and ensuring its correctness as per applicable regulatory requirements (Clinical). • To impart training on quality assurance principles and auditing procedures to new and existing personnel. • Archival of study related documents as per SOP/Protocol requirement. • Daily reporting to section HOD.• Note: Any other work allotted by Quality assurance HOD. Show less

  • Quality Assurance Auditor

    Jun 2021 - Jan 2022

  • Junior officer Quality Assurance (Clinical)

    Nov 2020 - Jan 2022
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  Sitec labs pvt ltd

  Sept 2021 - now

  Quality assurance auditor

  • Creating Quality Systems, procedures and amendments.• Periodic self-inspection, vendor audit and technical audits to ensure compliance with Good Laboratory Practice, Good Clinical Practice and Quality Management System.• Ensure the execution of Good Clinical Practices and Safety Procedures. • Implementation and when needed establishment of quality system.• Assure that appropriate calibration, Validation and preventive maintenance of equipment and laboratory instruments are conducted as scheduled.• In-process Audits of various activities like IP recipient activities, Dispensing activities, Dosing activities, Phlebotomy area Sample separation, Vital signs etc. During the course of the Clinical Study.• Checking Bioclinical Data (retrospective audit) like ICF, VCF, eCRF, Master Binder, Other relevant documents (ORD) and IMP Documents. etc.• Scanned CRF and other relevant project specific documents etc.• Storage and issuance of Documents with QA, QA Master Documents and Bioclinical Data.• Archival and Retrieval of Documents from External Archival.• Review and Issuance of log books.• Checking of volunteer data sheets and pathology report.• Issuance of CRF and ICF Sheets.• Any other assignment allocated by Head operations Quality Assurance/Head Quality Assurance Show less