Hi I am a Pharmaceutical Consultant, Trainer, certified and skilled freelance GxP, QMS, OH&S, EMS lead auditor and Surveillance Dosage reporter for Clinical Surveillance Project at CROs. I am a Certified lead GxP auditor from multiple third party auditing agencies located in India, USA, United kingdom, Germany, Spain, France, Italy, Ireland and an independent consultant with expertise in performing gap analysis in various functions and have performed remote and on-site First Party, Second party & Third Party audits of manufacturing sites engaged in manufacturing of different commodities, sophisticated materials such as drug products (Privately coded products for clinical trials and products at commercial scale), Active Pharmaceutical Ingredients (privately coded NCEs, clinical trial APIs, APIs at commercial scale, APIs of microbial and fermentation origin), Key starting materials, Intermediate, Excipients (Animal, chemical and plant derived), Medical devices, Primary and printed secondary packaging materials in line with applicable ISO standards and the required regulatory standards such as Schedule M India, ICH Q7, EudraLex volume 4 – Part I and Part II, IPEC, USFDA 21 CFR Part 210 and 211, Part 11 , PICs, warehouses and Transporters (Ground, air and sea line) and Clinical Surveillance reporting during reference listed and test sample dosing. I am an expert in conducting remote and on-site audits and creating the relevant audit reports. I have performed more than 360 remote and on-site second and third party audits across India, Europe and Asian regions.