Nagaraj Pushparaj

Background

About Nagaraj Pushparaj

14 years in Quality Systems/Regulatory affairs (Pharmaceuticals, Medical devices (MDD, MDR and IVDR) and Clinical research). Experienced Quality Assurance with a demonstrated history of working in the research industry and Manufacturing Industrial Non Sterile and Sterile). Skilled in Corrective and Preventive Action (CAPA),QMS documentation(Drugs, Medical device and Research field). Good Laboratory Practice (GLP), Life Sciences, Validation, and GMP. Strong quality assurance professional. FDA 21 CFR 820 QMS Certificate, ISO 9001:2015 and ISO 13485 :2016 Skills and sound Knowledge on: Risk management, PMS, Clinical Evaluation 1. Quality checks : IPQA checks during manufacturing(Non sterile and Sterile),Clean room concept and air-born classification, sterility test, Process validation for EO and gamma, product and steam sterilizations, Shipping validation, Review of stability (real time/accelerated) studies. QA : cGMP/GLP compliance, scheduling internal quality audits, BMR preparation and review, Site Master File, Quality Manual, COA’s/MSDS, validation protocols, raw data’s reviews in operations,Change controls, Deviations, OOS, OOT,CAPA initiation & close- out, GAP analysis,quality objective, handling of SPC software, preparation of medical device file etc.