WorkQuality Manager, Pharmaceutical GMP Professional & Quality Auditor
Industry Medical / Health Care / Pharmaceuticals
About Over 15 years of versatile, industrial experience in various functions like Corporate QA/ Site QA/ Global Quality Management / Production for API and Formulation facilities (approved by various regulatory agencies USFDA, TGA, MHRA, WHO etc.) of top pharma companies in India.
Wide experience in complying various cGMP regulations/ standards such as 21 CFR, ICH, WHO guidelines, EMA regulations, PIC/S, EU-GMP, Canada GMP, TGA GMP, ISO 9001, ISO14001, ISO 19011 etc.
Well versed in design of various types of quality management system documentation such as quality manual, SOPs, work instructions, site master file, corporate guidance documents, employee training program, vendor management