Vikas Nakrani

Work History

Work History

Pvt. Ltd

Pvt. Ltd
Duration: 12 week Project Title-“ Blood typing and pathological diagnostic test.” Step up labs,., station road, Surat, Gujarat, India-395004

Officer R&d

Span Diagnostics Pvt. Ltd.
Officer R&D.(6 months) Key Responsibility/Accomplishments Design and development of new In vitro diagnostic products and biological products and up gradation or improvement of existing products. Designing and validation of production facility for mass scale production of In vitro diagnostics assays. Validation, verification and review of new developed technology including accelerated temperature Stability study of kit. Preparation of Documentation for design dossier and technology transfer dossier as per ISO 9001: 2008, ISO 13485: 2003 and CE requirements. Root cause analysis for product failure and raise corrective action and preventive actions for the same. Technology Transfer of new developed or out sourced technology to production and scaling up from lab scale to production mass scale. Evaluation and validation of Kit as per approved specification. Projects/Trainings “ Development of HCV ELISA kit for detection of HCV virus from plasma sample”.

Biologist

National Institute of Biologicals Ministry of
April 2014 to Biologist Welfare, Govt. of India) Noida. India.(1.3 yr.) Key Responsibility/Accomplishments Quality Control Evaluation of various immunodiagnostic kits for various markers like HIV/HCV/HBV/SYPHILIS/COMBO Kits for the detection of Ag/Ab from indigenous manufacturer as well as importers in India. QC Evaluation of Molecular Diagnostic kits for various marker for the detection of viral RNA/DNA. Preparation of panel for the HIV, HCV, SYPHILIS, HBsAg, Anti-HBsAg, HBeAg, Anti-HBeAg, HBc, Anti-HBc for QC Evaluation of IVDs and Molecular Diagnostic kits. QC Evaluation of various RAPID, ELISA, CLIA, LATERAL FLOW, FLOW THROUGH, COMB Based Assay, CONFIRMATORY Assay and Molecular assays manually as well as on automated system. Characterization of panel samples for the various markers for QC Evaluation Purpose. Testing, Documentation and Report preparation of batches under QC Evaluation as per Lab SOP. Preparation of SOPs by following various guidelines like CDC/WHO and others. Maintenance of lab data as per NABL/ISO clauses and lab SOPs. Calibration and validation of various lab Instruments. Instruments handling Essential IVD lab instruments, PCR, HPLC, and other chromatography instruments. Various automated systems for immunoassay testing/Molecular diagnostic assays testing-(Cobas e 411 analyzer of ROCHE, EVOLIS of BIO-RAD, BECHMEN COULTER Access 2 Immunoassay system, BIO FLASH of WERFEN.)

Education

Education

B.Sc

Sardar Patel University

M.Sc

Amity University

Skills

Skills

well

Mining

FLAIR

immunological research

Productivity

Organisation