Profile: Over 16 years of progressive and versatile experience working in aseptic manufacturing and quality assurance with leading pharmaceutical firms. Career has been inclusive of exposure to site and global functions specifically site exposures into aseptic manufacturing, validations & quality operations and global exposure into supplier audits and supplier management functions. Major strength in Quality Management Systems, Validations & Qualifications, Aseptic Manufacturing, Quality Audits & Supplier Management. Regulatory Audits participated in USFDA, MHRA, MCC, TGA, EDQM, AGES, PMDA, ISO and other country regulatory agencies from Iraq, Turkey, Kenya, Egypt etc. Primary expertise in Global Quality Compliance. Supplier Management (Supplier Approval, High Risk Supplier management, Remediation of critical suppliers), Quality Audits Management (Global Audits, Third Party Audits) , Quality Management Systems (Investigations, CAPA, Change Control) ,Aseptic Manufacturing (Dry powder, Lyophilized) including Aseptic process simulation, Smoke studies , Validations (Process & Cleaning) ,Qualifications (HVAC, Water, Nitrogen, Compressed Air, Pure steam, Lyophilizer, Steam Sterilizer, Tunnel sterilization. Can audit within Europe. Currently in Germany. Language expertise: English, Hindi Malayalam.