Manoj Vishwakarma

Lead Auditor for EN ISO 13485:2016, EU IVDR 2017/746, EU MDR 2017/745, MSDAP. Technology Auditor for IVD Products. IRCA Certified Lead Auditor for ISO 9001:2015. Local technical reviewer for EN ISO 13485:2016 and IVD. Handling clients project/s for EN ISO 13485, IVDR, MDR, MDSAP, ICMED issue 2 ( involves processes like application management, assisting in defining the Scope, Applicable Codes for a particular device, TD planning etc.)

Manufactured various biochemistry products (Reagents, Standards, Calibrators) and Hematolgy products (Lyse, Rinse, Cleaner). Actively participated in various stages of D & D and manufacturing Electrolyte Analyzer (InstaLyte), Prepared and revised, documents related to products and processes. (MFR, BMR, SOP, Records and formats.). Validation of formulation process for Biochemistry reagent and standard, Hematology reagents. Calibrant for Instalyte. IQ, OQ, PQ of equipment.

Formulation, Development and manufacturing of Lateral flow immunoassays products (HBsAg and HIV 1 and 2 Ag test, Malaria Pan/Pf) Manufacturing of Blood grouping anti-sera (ABO). Prepared and revised documents related to products and processes. (MFR, BMR, SOP, Records and formats.). Validation of formulation process. IQ, OQ, PQ of equipments, Microfluid dispenser machine, oven, Band sealer machine, Printing machine, Vial filling machine.

Formulation and Troubleshooting of Lateral flow Immunoassays (Malaria Ag, Pan/Pf, Pv/Pf & only Pf) The process involved is colloidal gold preparation, Antibody-colloidal gold conjugation and Buffer preparation. Production planning of Uncut sheets. Preparation of documents for the Production department.