Deepak Bageshwar

Background

About Deepak Bageshwar

Pharmaceutical quality assurance (QA) professional with more than 11+ years of experience in quality management systems with a demonstrated history of working in the pharmaceutical industry and contract service provider. • Strong administrative professional with a Master of Pharmacy degree in Pharmaceutical Quality Assurance. • CQI – IRCA Certified ISO 9001-2015 Quality Management System (QMS) Lead Auditor. • Pharmacovigilance Quality Assurance (QA) Auditor. Experienced in various pharmacovigilance audits such as global systems & process audits, affiliates/subsidiary audits, business partners audits, and service provider audits. • Clinical Quality Assurance Auditor. Experienced in auditing of phase-3 clinical trials (Biosimilar & small molecules) at investigator sites. Experienced in auditing of bioequivalence studies (clinical & bioanalytical phase). • Experienced in conducting the qualification audits of vendor/service providers/suppliers. • Experienced in implementation of global QA functions, audit programs and regulatory inspections. • Competency in Quality Management Systems (QMS), SOPs, CAPA, deviation & change control management, training management. • Competency in GCP, GVP, ICH, 21 CFRs, USFDA, EU, TGA and other regulatory requirements.