SUNIL KULKARNI

Microbiology postgraduate from Savitribai Phule University of Pune, currently working as Manager - Quality, Vaccines and antisera with rich experience (15+ years) in in-vitro and in-vivo QC assays pertaining to Diphtheria and Tetanus based vaccines and combinations. Expertise in management of in-house reference standards, document review, analytical method validation, lab management, audit presentations and compliances. Very well versed with quality aspects and regulatory requirements of biological products along with Quality management systems QMS - (CAPA, Audits and compliance, Deviation, Change Control, Trainings, OOT/OOS/IPQR, Batch file review and release, Process and method validations). Expertise in designing and implementation of alternative in-vitro assays for replacement, refinement of in-vivo assay and reduction in total number of animals used in the QC assays. Very well knowledge of various routes of injections in animals, animal housing and handling. Rich experience in QC assays pertaining to various stages of Diphtheria and Tetanus Toxoid production. Expertise in cell culture assays and various ELISA's. Trained certified internal auditor responsible for internal auditing of various departments in co-ordination with QA and sound knowledge of digital platforms (Trackwise, eDMS, eLMS, LIMS, SAP QM etc)