Profile: Two decades of experience in the field of API QMS, failure Investigations, audits & compliances. Worked with topmost Indian Pharma. companies i.e. Lupin, Orchid and Dr Reddys (DRL). Over 50 API new products validation from R & D scale to commercial scale. Outstanding work in audits, remediation and compliances of various EDQM, USFDA WL sites. Outstanding work in vendor management, investigation and compliances at new takeover site. Independently handled two remediation and compliance projects at site for USFDA and EDQM queries. Expertise in API - process validation, Computer system validation, Marketing coordination, Cleaning validation, Failure investigations, Change management Remediation & Compliance ,IPQA activities ,QMS management, Employee trainings ,CMO activities/Clinical trials support ,Hosting customer audit ,Product risk assessment ,Mock audits ,Vendor management. Auditing India, Brazil, USA, Germany, China, Turkey, Italy etc. Language Expertise: English, Hindi, Marathi, Telugu. Based in Hyderabad.