President, Rajamani Group LLC, Milltown, NJ, USA
Raj is the consultant for Healthcare Industries and has provided consulting services since 2011 in the areas of Pharmaceuticals (Rx and OTC Drugs), Biotech, Cosmetics, and Dietary supplements. Raj is a Quality Assurance and Compliance Professional with expertise and a proven record of success in the Design and Implementation of Quality Systems and Manufacturing Systems. Raj has more than 50 years of industry experience and has worked in pharmaceutical research, development, and formulation, pharmaceutical and biotech production, project and process engineering, validation and process automation for Pharmaceutical, Biotech, Cosmetics, and Dietary Supplements products during his career at Pfizer Inc., NY, GlaxoSmithKline (GSK) Phila, Baxter International Chicago, IL, Bristol Myers Squibb (BMS), NJ, Union Carbide CT, & France, Italy, and Belgium Atomic Energy Consortium, Boston, MA. He is presently providing consulting services to major Pharmaceutical, Biotechnology, Medical Device, Cosmetics, and Dietary Supplements companies globally in all areas of regulatory and cGMP compliance.
Retired from Pfizer Inc. since 2011, as an independent consultant, Raj routinely provided consulting services to Pharmaceutical (FDA 21 CFR 2010/211, EU cGMPs, WHO, and India GMPs), Biotech, Dietary Supplements (21 CFR Part 111), and Cosmetic Industries (ISO 22716:2077 & FDA Cosmetic Guidance).
Raj is the past Chairman of the American Society for Quality (NEI Section, Chicago), and served as an Officer or Director of ASQ-NEI, and a member of the editorial advisory board of American Pharmaceutical Outsourcing magazine. Author and frequent speaker about quality management systems (QMS), FDA/EU/WHO Pre-Approval Inspection (PAI) & Regulatory Inspections, and regulatory compliance in pharmaceutical and biotech industry. Raj was a Global Health fellow in Christian Medical College Hospital in Vellore, South India. For this work, he was nominated and awarded the Golden Apple Award by the Health Volunteers Overseas (NGO) in 2007 and 2012. Raj also served as a Scientific and Technical Advisor to the Board of Chakra Biosciences USA. He is presently serving as a Foundation Member in the Vellore Christian Medical College Foundation (USA), Inc.
In October 2019, Raj, received certifications in auditing from the Global Retailer and Manufacturer Alliance (GRMA) consensus – based standards (NSF/ANSI 455-1, 455-2 DS, 455-3 Cosmetics, and 455-4 OTC Drug GMPs). In June 2020, he received certification in Quality Management systems, Lead Auditor.