Proflie: Seasoned GMP Quality Assurance and Regulatory Affairs Consultant 23 years of quality assurance experience in GMP across the pharmaceutical industry. Proven leadership in the strategic development, execution and management of Quality Management Systems. Expert in conducting a variety of GLP and GMP audits (including for-cause audits) in different countries and preparing for and hosting regulatory inspections. Completed 600+ audits for various standards i.e. 21CFR Part 210,211, 21CFR Part 111,21 CFR Part 820, ICH Q7, ISO13485, ISO9001,NIOSH (CDC audits), EUGMP, Packaging, Health Canada audits, new small molecule drug product(DP) facility and new biological drug substance (DS) facility and the corresponding QC labs and various other standard. Audits in Aseptic processing of injectables, Sterile Ophthalmic site. Experience in the delivery of QA services to customers. International Audit Experience: USA, Netherlands, Belgium, France, Italy, Sweden, Denmark, Czech Republic, Saudi Arabia, Srilanka, Bangladesh, Turkey, Switzerland, Israel, Vietnam Areas of Audits and Training, GMP, GDP, GCP, GLP, GRMA and Regulatory Affairs. Current City: Mumbai. Language Expertise: English, Hindi, Marathi, Gujarati.