Freelance GMP auditor and Pharmaceutical Consultant

I am a Pharmaceutical professional with a rich experience into Quality assurance area and GMP audits of suppliers. I am an independent consultant and a freelance contract GMP Auditor with expertise in performing gap analysis in various functions and performing GMP audits at manufacturing sites of finished formulations, Active Pharmaceutical ingredients (API), Intermediates, Excipients, Packaging Materials in line with required regulatory standards such as Schedule M India, ICH Q7A, EudraLex volume 4 – Part I and Part II, IPEC, ISO 15378, USFDA 21 CFR Part 210 and 211 and PICS.
I am expert in conducting supplier audits and performed more than 260 site audits across India, Europe and Asian regions.

Currently handling projects: On-site and remote GMP audits of manufacturing sites engaged in manufacturing of finished products, Active pharmaceutical ingredients, Intermediates, key starting materials, pharmaceutical excipients, medical devices, primary and printed secondary packaging materials in line with required regulatory standards like Schedule M India, ICH Q7A, EudraLex GMP volume 4 – Part I and Part II, IPEC, ISO 15378, Schedule M India, USFDA 21 CFR Part 210 and 211 and PICS. Gap analysis, GMP consultation and Subject matter expert trainings in line with the current regulations and good manufacturing practice guidelines.