About 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.
Experience
- 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
Education
Qualification / Affiliation | Institute / University | Year | Score |
Bachelors in science (BSc) Chemistry | Sri Satya Sai Institute of Higher Learning, Prashanthi Nilayam | 1990 - 1993 | 82% |
Masters in Science (MSc) Medical Biochemistry | JIPMER, Pondicherry | 1993 - 1996 | 72% |
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
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