An NSF International Company Mr Puthucode N. Rajamani
Consultant
MS
- [email protected]
- + 1 857 277 0060
Raj is the President of “Rajamani Consulting Group, LLC” and 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 extensive experience working with both major pharmaceutical companies and contract manufacturers on a global basis.
Raj has more than 40 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 during his career at Pfizer Inc., Smith Kline Beecham, Baxter International, Squibb, Union Carbide, France, Italy, and Belgium Atomic Energy Consortium. He is presently providing consulting services to major Biotech and Pharmaceutical companies in all areas of regulatory and cGMP compliance.
Raj has a comprehensive and working knowledge of GXPs, ICH, and ISO 9000 Standards.
He has extensive experience in dealing with FDA and international Regulatory Agencies. He has hands on plant operation management and consulting experience in Pharmaceutical and Biotech industry with international experience. He has successfully developed and implemented key Quality Systems which have improved overall performance while reducing compliance risk.
He is a past Chairman of the American Society for Quality (ASQ NEI Section) and served as an Officer or Director from 1982 to 1988. He was a member of the editorial advisory board of American Pharmaceutical Outsourcing. He is a frequent author and speaker on the subject of quality management systems, audits, CAPA, risk assessment, and regulatory compliance in pharmaceutical and biotech industry.
Raj is a senior member of ASQ and was a Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE). Raj was also certified by the RABQSA International as the ISO/Quality Management Systems Lead Auditor.
Raj was a Pfizer 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. He is presently serving as a Foundation Member in the Vellore Christian Medical College Foundation (USA), Inc. Raj is also serving as a Scientific and Technical Advisor to the Board of Chakra Biosciences USA.
