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SIVAKUMAR GAJENDRAN

Contact No 91-944*******

Email Id: adirjp@r.postjobfree.com

Skype ID: gajendransivakumar LinkedIn P r o f i l e https://www.linkedin.com/in/sivakumar-gajendran-13b70112/ Looking forward to challenging assignments in Medical Sector where a strong background in Lab Management and quality can be put to the best use

A well-qualified and resourceful Laboratory Manager with more than 25 years of experience in medical laboratory technology and highly adept at Laboratory Medicine. Possesses good knowledge of quality systems, and has decent exposure in areas of diagnostics, Stem cell banking and IVD distribution. I am a person with strong ethical aspects and dedication to serve the community and grow in self by developing the company as well as community

• Laboratory Management

•

Operations

Validation

Microbiology

Cord Blood

• Stem Cells Quality Systems LIMS Documentation POCT

• Leadership SOP GMP

Accreditation

Auditing

Designation: Qualified Professional

Job Responsibilities

• In charge of organization in Operations, Quality, Financial and Regulatory aspects. Designation: Quality Manager

Job Responsibilities

• Maintain the achieved ISO 15189:2012 Accreditation and GYS 170:2003 Certification.

• Maintains department records, reports and statistical data as required.

• Develops laboratory goals and objectives in conjunction with the Medical Director.

• Maintain Occupational Safety and Health standard with reference to GYS235:2009

• Assists with the development and management of the department budget.

• Establishes and maintains laboratory policies and procedures.

• Participates in internal/external assessments.

• Develops standards of performance, train and perform competency assessments.

• Conduct laboratory quality and variance programs.

• Conduct process improvement programs for the laboratories.

• Facilitates department staff meetings and attends other meetings as assigned.

• Enhances professional growth and development for self and staff.

• Performs other duties as assigned or requested.

• Coordinate with National Standards Bureau in Quality exchange program Designation: Application Specialist

Job Responsibilities

• Lead Medical scientists in providing technical support to regional technical team.

• Execute IQ, OQ and PQ documentation for Newly installed Equipment’s.

• Coordinate with end users in Interface of URYXXON 500 and URYXXON Relax urine analyzers to Laboratory Information Management System and Hospital Information management System.

• Perform Periodic Preventative maintenance and Annual Calibration procedures on URYXXON 500 and URYXXON 3. BHR DIAGNOSTICS PVT LTD, INDIA Jan 2015 to Jan 2017 2. Dr. Balwant Singh`s Hospital Laboratory,

Georgetown, Guyana, South America (A2LA Accredited) Feb 2017 to Jan 2019 1. BHR Diagnostics Private Limited Feb 2019 to Till Date KEY SKILLS

SUMMARY

LABORATORY MANAGER -OPERATIONS / QUALITY

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Relax Urine analyzers.

• Support designated region with specific domain expertise and the products that they represent

• Execute custom/highly configured demos in support of pre-sales activity

• Demonstration support: Collaborate with all Field Bio-Medical Scientists Team members to develop and deploy world-class demonstration systems and tools and provide front-line support to sales as the product specialist in the responsible region.

• 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.

Designation: Laboratory Manager

Job Responsibilities

• Acting as Lab In charge and handling quality systems, implement ISO Standards in developing third world

• Training regional staff in laboratory systems

• Coordinating with country lab manager in implementing national laboratory standards. Designation: Laboratory Manager - Operations / Quality Control Profile

• Assessor (Trainee): AABB Trained at Boston, USA by AABB (American Association of Blood Banks) in Cellular Therapy Quality Systems (International Society for Quality Approved Certification)

• In-charge of Umbilical Cord Blood Stem Cell Bank which is accredited for ISO, WHO GMP, AABB and NABL

• Trained for ISO 9000 Internal Quality Auditor (DNV & TUV)

• One of the active team members in implementing AABB Cellular Therapy standard for Umbilical Cord Blood in Life Cell International and Chennai and Cryo-save India Bangalore. Job Responsibilities

• Oversee day-to-day lab operations

• Training & development of lab staff

• Lead laboratory team for all audits where applicable.

• Work closely with Medical Directors for any laboratory-related issues that require medical oversight

• Ensure timely processing of all cord blood units

• Knowledge in hematology and serology, Microbiology, cryopreservation

• Knowledge of Clean room, Maintenance, and validation

• Responsibility for competency testing and ensure adherence to documented procedures and protocols

• Ensure lab proficiency testing and controls

• Develops operational efficiencies and improvements

• Perform design control and validation studies in process change development

• Monitor process deviations and ensure timely implementation of corrective and preventive actions.

• Interface with doctors and internal staff to ensure adherence to lab and regulatory requirement

• Responsible for maintaining safe and clean working environment in the lab Designation: Lab Supervisor

Job Responsibilities

6. LIFE CELL INTERNATIONAL Jul 2005 to Apr 2008

5. CRYO-SAVE INDIA PRIVATE LIMITED (WHO cGMP, AABB, ISO and NABL ACCREDITED CORD BLOOD FACILITY) Apr 2008 to Dec 2012 4. ECOMED SIERRA LEONE, West Africa Mar 2013 to Aug 2014 Page 3 of 3

• Acting as In-charge of the cord blood processing and cryostorage division, flow cytometry lab and infectious diseases laboratory

• Performing commendable practice as per AABB regulations

• Managing cord blood processing with 6000 samples on hand experience (open vial method- density gradient with LSM, closed bag method- volume reduction with HES

• Ensuring cryofreezing and cold storage

• Knowledge of Flow Cytometry with hands on technique experience (Single Platform with Ishage Protocol)

• Proficiency in Elisa Techniques

Designation: Senior Technologist

Job Responsibilities

• Performing analysis of routine biochemical, clinical hematology, drug assay, Endocrinology, blood bank procedures

• Phlebotomy

• Managing Medical data

• Ensuring internal and external quality control

Designation: Tutor

Job Responsibilities

• Teaching and training Medical Laboratory Technician students

• Assist with PhD research scholars in Lab Project activities

• As an Assessor Trainee with the American Association of Blood Banks, wish to serve the community by delivering quality system

• Member – American Association of Blood Banks

AABB- Cord Blood Sub Section,

CT Quality Operations Sub Section,

Regulatory Affairs Subsection

Cellular Therapy Asia Pacific Group

• Member- African Society for Laboratory Medicine

• International AMBASSADOR for AABB Cellular Therapies.

• Master of Science in Medical Laboratory Technology (MLT) in the year 2011

• Certificate in Medical Laboratory Technology (Pathology, Biochemistry, Microbiology, Histopathology, Transfusion Medicine) in the year 1995

• Bachelor of Science in Zoology in the year 1993

• Laboratory Information Management Systems

• Windows

• MS Office (Excel and PowerPoint)

PERSONAL DETAILS

Date of Birth : May 13, 1972

Address : 67, Kalaignar Nagar, Kovilpadagai, Avadi, Chennai, Tamil Nadu, PIN-600062, India

Languages Known : English, Tamil and Telugu

• Mr. Ramesh Patel – Managing Director, BHR Diagnostics Pvt Lts(adirjp@r.postjobfree.com)

• Mr.Kassem Daher – General Manager, Ecomed, Sierra Leone (adirjp@r.postjobfree.com)

• Marc Waeterschoot – Founder & Director, Cryo-Save Group Belgium (adirjp@r.postjobfree.com) REFERENCES

IT SKILLS

EDUCATIONAL QUALIFICATIONS

INTERESTS & MEMBERSHIPS

8. INSTITUTE OF LABORATORY

TECHNOLOGY

Jun 1995 to Jan 1997

7. MADRAS MEDICAL MISSION Jan 1997 to Jun 2005

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• Dr. Aasawari Bapat, Director, Questar Enterprises, Dubai (adirjp@r.postjobfree.com)

• Dr. Saibabu, Head Blood-bank & Laboratory(Frontier Lifeline Hospitals-International Center for Cardio Thoracicand Vascular Diseases) (adirjp@r.postjobfree.com)

• Dr. Srinivas Chakravarthy – Head of the department of Transplantation and HLA Lab, MIOT Hospitals, Chennai(adirjp@r.postjobfree.com)

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