Varun Kumar Email & Phone Number

Approved as Analytical Chemist by Drug Authority, Solan (Himachal Pradesh) for diagnostic kits &reagents.- Accomplished  & result-driven QA,RA management professional having 14 years of experience in QA, RA, QC and Production in the Medical Device Industry.- Skilled in implementation of QMS as per ISO 13485 2016- Skilled in documentation as per MDR 2017, MDD 93/42/EEC - Worked in the Production, QC, QA and RA departments. - Skilled in identifying loopholes in the system and removing them. - Skilled in Risk assessment, Internal, External/Regulatory Audits, Production planning and resources allocation, Providing Training regarding MDR, QMS, Executing QA, QC and Production operations, Product approval, Vendor development and Qualification (local and foreign), Handling Customer Complaints and feedback system,PMS, Developing and Qualifying and system, processes, machines and material. - Skilled in sampling, testing and maintaining samples. - Skilled in developing special purpose machines(SPM) as per product requirement. - Skilled in handling QC testing(RM, PM, FG and IP), stability testing(In-use, accelerated, real-time and transport simulation) and result interpretation. - Skilled in negative and positive panel validation, method validation. - Skilled in manufacturing class C and D IVD medical devices and reagents such as HIV Tridot, HCV Tridot, Lateral flow-through kits, Thromboplastin reagents, Buffer solution and Conjugate solution.- Skilled in document preparation for Class B medical devices such as Cannula, blood transfusion set,oxygen masks, IV Set - Skilled in leading, directing and motivating manpower.- Worked as Management representative.