Rajendra Kumar

Healthcare professional with 25 plus years of experience in playing Managerial Designer role in developing QualityManagement Systems includingHospitals, Clinical Research, Biotechnology Industryand Clinical Laboratories.

*Quality manager and advisor to the organizations’ worked with in developing and implementing theirQuality systems.

• Designer of solutionsfor clinical laboratories with a good hold on Lean Six Sigma, NABH / NABL accreditation, ISO standards, Operations and Quality and Administration management related to Healthcare Industry.
• Experienced in implementation of IT relatedservices in ClinicalLaboratories
• Experienced in setting up of laboratories including green field, Statutory and Regulatory requirements and Process design
• Expertise in design, development and implementation of Healthcare / Diagnostics / Life Sciences qualitymanagement systems
• Successfully implemented premier quality management accreditations including ISO 9001:2015, ISO 15189:2012, ISO 17025:2015 (NABL), ISO 13485:2016, CAP (College of American Pathologists), NABH, AABB, cGMP and GLP in the career spanning over18 years

Qualification / AffiliationInstitute / University Year ScoreBachelors in science (BSc)

Chemistry

Sri Satya Sai Institute of Higher Learning, Prashanthi Nilayam1990 - 199382%Masters in Science (MSc)

Medical Biochemistry

JIPMER, Pondicherry1993 - 199672% Trained on Laboratory Quality Management & Internal Audit by NABL during March 27 – 30, 2004, April 5-8, 2011, January 23-26, 2015, and October 2017

Certified Lead Assessor in ISO 13485:2016 Medical Devices Management System from TNV Exemplar Global in May 2023

Trained as NABH Assessor by QCI during July 19 – 23, 2008

Trained as ISO 9001:2000 InternalAuditor at Engineering Staff College of India,Hyderabad in March 2004,

ISO 9001:2008Internal Auditor Training by FIEO at Bangalore on May 20th and 21st 2011