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I am a Quality professional in the Pharma/Healthcare sector with a six Sigma Black belt certified with over a decade of experience in both Quality Assurance compliance and Quality control Microbiology with expertise in quality systems. I am currently handling Corporate Quality Audits of all CMO sites, vendors, third parties of SUN Pharma and SUN affiliates globally. I was heading the Quality Assurance Audit and Quality compliance, Vendor management and Training and development at Caplin Steriles limited. Prior to above I was Heading Quality Control Microbiology Department handling Biologics products, Small molecules products and formulations business units of Syngene. Also involving in cGMP trainings, technical trainings, conducting internal and external audits, Handling of audits (Regulatory and customer) . Had the responsibilities of harmonization of cGMP documents across the five sites of the Biocon as a lean document system approach and to bring about common quality systems. Expertise in handling Small molecules DS/ DP and Biosimilar products derived from Bacterial cell line, Yeast Cell line and Mammalian Cell line.
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