Puthucode N Rajamani
Puthucode N Rajamani President, RAJAMANI GROUP LLC, Milltown, NJ, USA
Puthucode N Rajamani President, RAJAMANI GROUP LLC, Milltown, NJ, USA Raj is the President of “Rajamani 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 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., GSK (SmithKline Beecham), Baxter International, BMS (Squibb), Union Carbide, France, Italy, and Belgium Atomic Energy Consortium. He is presently providing consulting services to major Pharmaceutical, Biotechnology, Medical Device companies globally in all areas of regulatory and cGMP compliance.
Raj has extensive experience in dealing with pharmaceutical oral solid dose products. Between 2011 and 2016, Raj routinely provided consulting services in Quality and Manufacturing Management Systems; Audits, Risk Assessments, Due Diligence; Regulatory, Quality and Compliance gap analysis; Deviation & CAPA Investigations; Validations; Remediation; Regulatory Inspection & PAI readiness supporting Manufacturing, Quality and Regulatory compliance.
Raj is the past Chairman of the American Society for Quality (ASQ NEI Section) and served as an Officer or Director from 1982 to 1988. Member of the editorial advisory board of American Pharmaceutical Outsourcing. Author and frequent speaker on the subject of 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. 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. Conf No: 96678047 ISO Conf: Checked LSS Conf: Checked
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“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.
The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”
An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013