Profile: + 33 years of experience in Pharmaceutical Quality Systems and quality control as per global GMP and GDP standards. Experience of performing and hosting USFDA, EDQM, TGA, PMDA, KFDA, customer’s audits, internal audits, Third party Audits. Good Verbal and Communication Skills. Implementing of Quality Management Systems (QMS) in throughout organization as per ICH, CFR, Eudralax, WHO Guidelines. Good analyzing and problem-solving skills in pharmaceutical quality matters. Expertise in Failure Investigations and CAPA implementation. Third Party Audits. GMP Trainer. Audited more than 25 API manufacturing Highly regulated facilities in India in last 12 months, audited more than 50 facilities including Chinese. OK with English speaking countries, China, and worldwide any countries with the help of translator. Language expertise: English, Hindi. Based in Vadodara, Gujarat, India