Dharmesh Vaghasiya Email and Phone Number

1.Designing and validation of production facility for mass scale production of In vitro diagnostics assays 2.Searching new technologies in field of In vitro diagnosis.3.Design and development of new In vitro diagnostic products and biological products.4.Up gradation or improvement of existing products time to time.5.Monitoring and supervising group of research scientists..6.Give training for Managing and Handling of R&D projects.7.Preparation of Documentation for design dossier and technology transfer dossier as per ISO 9001:2008 , ISO 13485:2003 and CE requirements.8.Evaluation and validation of Kit as per approved specification9.Validation, verification and review of new developed technology including accelerated temperature Stability study of kit10.Technology Transfer of new developed or out sourced technology to production and scaling up from lab scale to production mass scale.11.New vendor development12.Provide training for technical information production team and production planning.13.Provide technical support to Marketing team and customer handling.14.Root cause analysis for product failure and raise corrective action and preventive actions for the same.15.To train sub-ordinates time to time

 Research and development of the Immunodiagnostic assays & its Quality Control Testing. Troubleshooting of the various immune-chromatographic assays.  Product transfer from R&D based to large scale production level.  Innovation in the existing lateral flow products for quality improvement and cost cutting.  Maintain R&D Lab. records as per WHO GMP/ISO requirement.  Stability Study (Real time and accelerated temperature).  Handling of all R&D instrument as well as large scale real to real production instrument.  Instrument Calibration & Validation. Handling of all the documentation work as per ISO 13485:2012 and ISO 9001:2008 

Protein analysis, Elisa and rapid assay Testing.  Work as per In Process Q.A., Finished product Quality Assurance and Quality Assurance check list.  Carry out the all Raw Material, In-process, Finished-product testing, Reserve/Retention sample testing Issue Batch release Certificate after completed the study.  Calibration of instruments & Analytical Method Validation.  Stability Studies of product as per ICH Guidelines.  To report regularly and discuss all matters participating day to day activities of the new development carried out in the laboratory