Manoj Vishwakarma
Angestellt, Auditor - Medical & Health Services, TÜV SÜD South Asia Pvt. Ltd.
Bis 2015, Master of Science in Biotechnology, School of Biotechnology and Bioinformatics, D Y Patil University
Mumbai, State of Mahārāshtra, India, Indien
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Authorized Lead Auditor for: (DIN) (EN) ISO 13485:2016, IVDR and MDR in accordance with new European regulations EU 2017/745 and EU 2017/746). MDSAP in accordance with all five countries jurisdiction (US FDA, Health Canada, Australia, ANVISA and Japan). MDQMS in accordance with NABCB schemes for Indian jurisdiction (ISO 13485:2016, ICMED issue 2, ISO 15378:2017). IRCA certified Lead Auditor for ISO 9001:2015 QMS. More than 5 + years of industrial experience in development and manufacturing of in vitro diagnostic reagents and instruments. 1+ year experience with Certification body and Notified body (TÜV SÜD South Asia) Local technical reviewer for EN ISO 13485:2016. Authorized Technology auditor for IVT2001,2002,2003,2005,2006,2008,2009,2011, all IVR codes, IVS1001,1002,1004.
Werdegang
Berufserfahrung von Manoj Vishwakarma
Bis heute 2 Jahre und 9 Monate, seit Okt. 2021
Auditor - Medical & Health Services
TÜV SÜD South Asia Pvt. Ltd.
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.)
2 Jahre und 8 Monate, Feb. 2019 - Sep. 2021
Production Executive
DiaSys Diagnostic India Pvt. Ltd
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.
1 Monat, Feb. 2019 - Feb. 2019
Production Executive
Voxtur Bio Ltd.
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.
2 Jahre und 2 Monate, Jan. 2016 - Feb. 2018
Production Officer
ADVY Chemical Pvt. Ltd.
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.
Ausbildung von Manoj Vishwakarma
2 Jahre, Juli 2013 - Juni 2015
Master of Science in Biotechnology
School of Biotechnology and Bioinformatics, D Y Patil University
Sprachen
Englisch
Fließend