Contact
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Sivakumar Gajendran MSc
MLT, PHA, CQA
www.linkedin.com/in/sivakumargajendran-msc-mlt-phacqa-13b70112 (LinkedIn)
Manager - Laboratory Quality Assurance & Operations, ISO 9001 &
ISO 15189 Lead Auditor, Public Health Administration
Chennai, Tamil Nadu, India
Top Skills
Summary
Assessor
I am a Experienced Quality Assurance and Laboratory Management
expert with over 28 years of multidisciplinary experience across
various global settings. My expertise lies in the implementation of
Quality Management Systems (QMS), achieving and maintaining
ISO 15189 and other critical accreditations, and leading laboratory
Six Sigma
GLP
Languages
Telugu
Tamil
Certifications
Impactful Data Governance
Diploma in Six Sigma
Principles and Behaviors of
Organizational Excellence
Leader Standard Work
Introduction to A3 Thinking
operations in both established and resource-constrained
environments.
Throughout my career, I've had the privilege of spearheading ground
breaking initiatives, including securing the first AABB accreditation
for stem cell banking in India as team member and pioneering ISO
15189 accreditation across South America. As a Quality Assurance
Manager at eHealth Africa, I successfully led the organization to
achieve JCI Accreditation and ISO 15189:2012 certification, while
also serving as a Management Representative to Accreditation
Bodies.
In addition to my technical skills, I am committed to advancing
industry standards globally.I have played a key role in drafting
national guidelines for Nigeria's laboratory programs.
My passion lies in enhancing healthcare standards through
continuous improvement and operational excellence. I am always
eager to connect with professionals who share my dedication to
quality and innovation in laboratory science.
Experience
Empowering Assurance Systems Pvt. Ltd.
Empanelment Trainer
December 2024 - Present (3 months)
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Chennai, Tamil Nadu, India
Train Internal Auditors and Lead Auditors for International Standards ( ISO
9001 (Quality Management), ISO 14001 (Environmental Management), ISO
45001 (Occupational Health and Safety), ISO 22000 (Food Safety), and ISO
50001 (Energy Management), ISO 15189 ( quality and competence of medical
laboratories) ISO 13485 (Medical devices - Quality management systems))
eHealth Africa
Manager - Quality Assurance / Laboratory Operations
February 2021 - March 2024 (3 years 2 months)
Kano, Nigeria
Organization Key Responsibilities:
- Manager of Country Labs with eHealth
Africa
- Laboratory Leadership
- Management Representative to Regulatory/
Accreditation Bodies
- Business Engagement(B2B)
- Community Reach Program Engagement
- Public Private Partnership Program
engagement
- Research Program Support
Achievements:
- Achieved JCI Accreditation in April 2022
- Achieved ISO 15189:2012 in May 2022
- Successfully engaged Community Reach
Program (Vision Springs) supporting
Leadership team
- Successfully established Laboratory
Academy
- Successfully established Procurement and Supply chain department for EHA
Clinics
- Initiated Public Private Partnership
negotiation for National drug testing
program( Clean Kano) with
Nigerian Drug Law Enforcement Agency
(NDLA)
- Successfully Acquired the Research
programs for Vanderbilt University
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- Team member in drafting National
Guidelines for the Federal Government of
Nigeria Laboratory Program
- Member eHealth Africa Clinics Quality
Committee
- Certified in Six Sigma
- British Standards Institute trained Quality
Auditor( Lead Auditor)
- Certified ISO 15189 Lead Auditor
BHR Diagnostics Pvt Lt
Qualified Professional
June 2020 - January 2021 (8 months)
Navsari, Gujarat, India
In Charge of National Operations and technical support
BHR Pharmaceuticals LTD
Consultant
November 2019 - June 2020 (8 months)
Nuneaton, England, United Kingdom
Establish Quality Management Systems and setup Laboratory as per ISO
13485 for the newly built facility
BSH GeorgeTown, Guyana, South America
Quality Manager at BSH, Georgetown, Guyana, South America
February 2017 - January 2019 (2 years)
Georgetown, Guyana
• Achieved first Laboratory Accreditation for the entire South America for A2LA
(American
Association of Laboratory Accreditation).
• Maintain the achieved ISO 15189:2012 Accreditation and GYS 170:2003
Certification.
• Train Regional staff on Quality Management Systems and Good Laboratory
practices
• Liaise with National Bureau of standards and be the focal person towards
QMS implementation
• Management representative for the Accreditation bodies.
BHR Diagnostics Pvt Ltd
Scientific Application Specialist
January 2015 - January 2017 (2 years 1 month)
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Chennai Area, India
• Focal person in scientific support for regional teams
• Execute and maintain regulatory documents.
• Tech support for LIS/ HMS related aspects for the device specific domain.
• Execute custom/highly configured demos in support of pre-sales activity
• Execute pre-sales pilots / workshops / evaluations for product area
• Supplemental support of canned demos as required in territory
• Coordinate with Product Management to identify, communicate and
incorporate new product enhancements and with the Services team to insure
we deliver competitive solutions that are differentiated through value as
perceived by our customers.
• Coordinate with Marketing Programs organization to develop and participate
in marketing program design and execution as needed.
Ecomed sierra leone
Laboratory Manager
March 2013 - August 2014 (1 year 6 months)
Free town, Sierra Leone
• Lab In charge and handling quality systems, implement ISO Standards,
training regional staff in laboratory systems
• Coordinating with country lab manager in implementing national laboratory
standards.
Cryo-Save India Private Limited
Laboratory Manager- Operations / Quality Control
December 2012 - March 2013 (4 months)
Bangalore
Assessor(Trainee):
AABB Trained at Boston, USA by AABB (American Association of Blood
Banks)
(International Society for Quality approved Certification)
Cryo-Save India Private Limited (WHO cGMP ,AABB, ISO and NABL
Accredited Cord Blood Facility)
Deputy Laboratory Manager - Operations/Quality Control
April 2008 - March 2013 (5 years)
Bangalore, India
• Lab In charge of WHO cGMP ,AABB, ISO and NABL Accredited Cord Blood
Facility
• Oversee day-to-day lab operations
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• Have hands on experience of more than 20,000 Stem cell Processing(Cord
Blood & Tissue)
• Proficiency of Clean room, Maintenance and validation
• Proficiency in Cryopreservation (LN2 Dewars, Controlled rate Freezers)
• Accreditation process
Life cell International
LAB SUPERVISOR
January 2005 - April 2008 (3 years 4 months)
In charge of the Cord blood processing and cryostorage division, flow
cytometry lab and infectious diseases laboratory
Perform commendable practice as per AABB regulations
ISO Internal Auditor Trained by DNV
Madras Medical Mission
SENIOR TECHNOLOGIST
January 1996 - January 2005 (9 years 1 month)
Shift In Charge of Clinical Biochemistry and Blood Bank
Performing analysis of routine biochemical ,clinical hematology, drug assay,
hormone assay ,
Blood bank procedures,
Phlebotomy,
Medical data management,
Quality control both internal and external
INSTITUTE OF LABORATORY TECHNOLOGY
TUTOR
June 1995 - January 1997 (1 year 8 months)
Job Profile: Teaching and Training technician students and assist in PhD
research scholars
IT Skills
Handle laboratory information management systems, windows, excel, power
point presentation etc
Education
Vinayaka Mission's Research Foundation - University
Master's Degree, Medical Laboratory Technology · (2010 - 2011)
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The Institute of Laboratory Technology, Govt of Tamilnadu
Certificate, Clinical Laboratory Science/Medical Technology/
Technologist · (1994 - 1995)
University of Madras
Bachelor of Science, Zoology · (1991 - 1993)
Iowa Department of Public Health USA
Public Health Administration Program, Public Health Administration · (January
2024)
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