Seetharam Kandarpa ASQ CMQ/OE, CPGP, CQA

Mumbai Area, India India

Quality Manager, Pharmaceutical GMP Professional & Quality Auditor

Medical / Health Care / Pharmaceuticals

 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