Rajeev Kumar Singh Email & Phone Number

Visakhapatnam, Andhra Pradesh, India

* Preparation, compilation and submission of documents for getting Test Licence and Manufacturing Licence for IVD Kits, reagents, instruments or analyzers and molecular diagnostics kits or reagents. * Preparation, compilation and submission of documents for Wholesale Licence from State Licensing Authority.* Preparation, compilation and submission of documents for Test evaluation Licence, Import Licence for IVD kits, reagents, instruments or analyzer as per regulatory compliance of Indian MDR 2017 and implementation of IVDR.* Liaisoning with regulatory bodies (State Licensing Authority, Central Licensing Authority) and other Licensing notified bodies. * Conducting internal quality audit as internal quality auditor for ISO 9001:2015 and ISO 13485:2016.

Rudrapur,Uttarakhand,India

* Accountable for overall auditing activities including certification audit and surveillance audit.* Implementation of Quality Management system as per regulatory compliance for ISO 13485:2016, Medical Device Rule 2017 and IVDR (2017/745).* Preparation and submission of records and documents as per regulatory compliance. * Conducting Vendor audit for raw material and packaging material vendors for IVD Kits & reagents.

Mumbai Area, India

* Testing of In–Vitro Diagnostic kits & reagents and ELISA kits as per product’s specification.* Testing of raw materials, packaging materials for In–Vitro Diagnostic kits & reagents and ELISA kits as per material’s specification. * Monitoring and Conducting stability studies for In-Vitro Diagnostic kits & reagents.

Gurgaon, India

* Monitoring procedure and conducting stability studies of In–Vitro Diagnostic medical devices. * Reviewing of art work design for packaging materials for In–Vitro Diagnostic medical devices. * Responsible for ensuring CAPA against Customer complaints of products. * Attending pre-bid meetings and coordinates with the project bidders. * Conducting clinical performance evaluation of In–Vitro Diagnostic medical devices. * To handle customer complaints and collection of consignee receipt certificates. * Experience in SAP Quality Management Module i.e. creating, editing of data and result recording.

Gurgaon, India

* To checkout in–Process Quality control parameters during manufacturing process.* Performing calibration of instruments and validation of process.* Inspection of critical raw material, packaging material and finished products.

B. Pharmacy From A.A.I, Pharmaceutical Sciences, A

Activities and Societies:  Industrial Training in Production and Quality Control (Arbro Pharmaceutical Ltd) at New Delhi.  Training.

P.G Diploma, Clinical Research And Pharmacovigilance, A

Activities and Societies: Clinical Research & Pharmacovigilance Clinical Trial on Medical Devices for study of hCG Test Devices, Malaria.

Schooling, From Vi To Xii Standard, A Grade

Activities and Societies: Quiz competition team