Profile: Accomplished pharmaceutical professional with over 23 years of experience in drug development, manufacturing, quality control, and regulatory compliance. Highly skilled in leading successful audits by regulatory bodies such as USFDA and MHRA, and adept at implementing robust quality systems and processes to drive right-first-time performance. Demonstrated ability to increase productivity and efficiency by up to 200% through better utilization of resources and processes. Proven track record of successfully executing green and brownfield projects from concept to GMP certification. Strong expertise in quality risk management, data integrity, and GMP regulations, with a deep understanding of the pharmaceutical industry's complexities. Adept at building and leading high-performing teams to deliver exceptional results, with a passion for continuous improvement and driving business excellence. Audit exposure: FDA – USA - As a lead auditee [Peter Backer], MHRA – UK - As a lead auditee [Fiona Routely and Richeal] , TGA- Australia, MCC- South Africa, GCC, WHO - As a lead auditee, NDA, Uganda - As a lead auditee, NVISTA, ANVISA – Brazil. Can audit in any country providing he gets required VISA. As a startup can start from UK, SCOTTLAND, NORTHERN IRELAND immediately as living in UK, Then can go for Middle East and Asean countries. Language expertise: Foreign: English ,Indian: Hindi, Gujarati, & Marathi. Based in United Kingdom.