ISO 15189 2012 STANDARD

RESUME

Objective

[pic] To meet a challenging opportunity in the

field of Biomedical Sciences and work with

Magesh.R dedication for the growth of the

organization with vivid academic knowledge

Email and effective technical skills.

acg0qk@r.postjobfree.com Educational Qualification

Mobile No M.Sc.,Biochemistry

S.R.M. Arts and Science College, Chennai.

+91-822******* (Affiliated to University of Madras)

Attained 58.2%(2005-2007)

Permanent Address

No-7,thiruvalluvar st, B.Sc., Biochemistry

Bhuvaneswari amman nagar, SRM. Arts and Science College, Chennai

Potheri-603203, Chennai. (Affiliated to University of Madras)

Tamilnadu. Attained 57%(2002-2005)

India

Personal Data HSC from Sri Rama Krishna mission

Vidayalaya boys hr.sec.school,

Date of Birth : Chengalpet.(2000-2002),

10/09/1984 Attained 72%.

Father's Name : SSLC from Sri Ramakrishna mission

Mr.M.Ravi Vidayalaya boys hr.sec.school

Chengalpet.(1999-2000)

Mother's Name : Attained 62.3%

Mrs.R.Shanthi

Sex :

Male

Nationality : Indian

Marital Status : Married

Language proficiency:

English, Tamil known to

speak, read and write.

Career synopsis:

> M.Sc., Graduate Specializing In Biochemistry, Having 7+ Years Of Rich

Clinical Experience In The Field Of Health Care.

> 7 years of experience as lab technologist in the organization and

execution of diverse analytical, haematology, Serology, Bio-Chemistry,

and clinical pathology, is seeking a career that will utilize my

education and professional skills in providing quality results.

> Proficient In Handling Latest Laboratory Equipments.

> Astute With NABL/ISO 15189:2012 Standards.

> Key Team Member In The Top Management In Taking Important Clinical

Diagnostic Decisions.

> Able Leader Experienced In Handling More Than 30+ Colleagues.

Technical Exposure :

Dept. Of Hematology

Technique : Flow Cytometry

Instrument : Sysmex Sf 3000, Beckmen Coulter Act 5 Diff Al .

Dept. Of Clinical Bio Chemistry:

Technique : Calorimetric Based Techniques

Instrument : Cobas C 311, Cobas C 501,KHB ZY220

Technique : ISE (Ion Selective Electrodes)

Instrument : Roche Electrolyte 9180, Easylyte.

Experience

Micro Therapeutic Research Labs Pvt Ltd, Chennai: Worked as Technical

assistant (Sep 2007- june 2008)

> Knowledge of Clinical Research guidelines (E3, E6,) and closing out QA

observations & Diagnostic Laboratory (NABL Guidelines 112).

> Conducting weekly training on SOP's, involved in sample separation,

segregation and its transportation, and Playing the role of custodian,

taking care in subjects well being, biological sample collection

(Blood) as per scheduled time points, organize other phlebotomist and

total QC audit of sampling area as per SOP, maintaining logistics for

sampling, ULTF, online documentation..

> Construct Study master file/Trial master file

> Assist in preparation and review of study related documents.

> Communication with outside personnel such as catering agency,

translating agency & dietician.

Reasons for leaving : Improve skills and update knowledge ( ISO 15189:

2007 )

Value Added Corporate Services (P) Ltd, Chennai: Worked as Executive

-Quality Management Services.(from Sep 2008 to April 2011 )

> Reviewing Process Adequacy Reports, Management System Manuals, Process

Manuals, Guidelines and Work Instructions.

> Performing System study, Gap analysis report, Corrective and

Preventive action (CA&PA),

> Implementation & Verification to comply standards based on Technical

and Non-technical chapters.

> Auditing the defined system to identify non-conformities and

improvements for Quality Management Systems. Quality System manual &

Quality System Procedure prepared.

> Internal Quality Audit carried out following the department -Front

office, Sample collection, Clinical Biochemistry, clinical

pathology, Haematology, serology HR &purchase.

> Knowledge of Clinical biochemistry, haematology,clinical pathology, serology Internal quality control, Biorad & CMC Vellore EQAS take

care of corrective action & preventative action.

> Internal Quality Audit report and MRM minutes prepared. Conducting

Management Review Meeting, & NABL 153 Application Annexure prepared.

> (SOP)Preparing the departmental manual of front office, collection,

clinical biochemistry( fully automated analyzers & semi-automated

analyzer), haematology, clinical pathology and serology.

> Closure of nonconformance raised from NABL Lead Assessor & Technical

Assessor.

> Type of closure of nonconformance: NABL Application annexure

adequacy reports closure Pre-Assessment assissment nonconformance

closure and Final assessment nonconformance closure. Training given to

laboratory staff awareness of NABL Audit. Coordinating with clients

and resolving any bottlenecks during the course of the project and

sharing challenges during project closure meeting. Preparing the

project plan estimation, Milestones, Identifying the resources,

scheduling the task and providing training to the Team members.

Reasons for leaving : Improve technical skills, daily operating

procedure diagnostic laboatory, training given to labtechnicain and

supevisory experience small size laboratory.( 5-7 labtechnicain staff )

Balaji Medical centre (P) Ltd, Chennai: Worked as laboratory quality

Manager from May 2011 to Feb 2013) .

> Overall responsibilities for entire clinical laboratory based on ISO

15189: 2007 Standard.

> Roles and responsibility assign to lab technician.

> Verify the daily internal quality control for clinical biochemistry,

hematology, clinical pathology and serology.

> Prepares daily work schedule of 10 employees to provide adequate

coverage at all times.

> Earmarking Standard Operating Procedure in the organization, for

ensuring Good Laboratory Practice and standards.

> Validated new assays or instruments by performing test runs of

linearity, accuracy, precision checks and developed new SOPs to ensure

accurate test performance.

> Verify and authorized final test report.

> Training contact to lab technician for laboratory technical area.

> Contact internal quality audit and Organising Management Reviews

and maintenance of Management Review meeting records

> Automated equipment annual calibration maintenance.

> Reporting to top management on the performance of the quality

management system and need for improvement (if any).

> Ensuring the processes needed for quality management system are

established and effectively implemented .

> Revised and updated Standard Operating Procedures as needed for NABL

> Ensures that all records, reports, statistics, logs, files, and

documents are reviewed and maintained as required by NABL

> Completed NABL Proficiency testing and competency evaluations of all

employees

Reasons for leaving : Improve diabetes test report interpretation and

supevisory for medium size laboratory(20-25 lab technician staff).

DR.V.SESHIAH DIABETES CARE AND RESEARCH INSTITUTE: Working as laboratory

quality Manager from May 2013 to till) .

> Overall responsibilities for entire clinical laboratory based on ISO

15189: 2012 Standard.

> Duty roasters assign the all laboratory staff.( 20-25 labtechnician )

> Verify the daily internal quality control for clinical biochemistry

and hormone assay.

> Verify and authorized final test report.

> Weekly conduct the training for lab technician.

> Ensure daily base quality control policies are implemented with

regular meetings and follow up whenever required.

> Ensure west guard rules following at level QC (I & II ) based on

Levey-Jennings chart .

> Reviewed and signed temperature charts, maintenance logs,

daily/monthly Q/C results of test runs and Q/C of test kit lot to lot

before put in use.

> Established analyte calibration schedule for routine clinical

biochemistry parameter.

> Established lab mean for routine clinical biochemistry parameter.

> Regular conducting technical area training for lab technician.

> Introduced new test parameter in semi-auto analyzer along with

training given to lab technician.

> Completed NABL Proficiency testing and competency evaluations of all

employees

> Existing test parameter change in other manufacture reagents before

use, validation done with equipment engineer.

> To help released in any abnormal test results at any time.( oral

communication night shift lab technician )

> To help performed CMC EQAS and RIQAS for laboratory quality of test

results.

> Any deviation occur in CMC EQAS and RIQAS, discuss with lab in-charge

to take necessary corrective action proposed.

> Quality control & NABL awareness given to lab technician.

> Handling maintenance and control checks of various equipments in the

laboratory.

> Coordinating with team members and other internal departments for

smooth execution of all activities.

* NABL Audit faced following Assessor

1.Dr. Thuppil venkatesh Lead assessor ( ISO 15189: 2007)

2.Dr.T.N.Raghunath Lead assessor ( ISO 15189: 2007)

3.Dr.Jothimalar Technical assessor ( ISO 15189: 2007)

4.Dr.D.Vijya Lead assessor ( ISO 15189: 2012)

5.Dr.Parithban Technical assessor ( ISO 15189: 2012)

Seminars & Symposium

> Participated in the Regional seminar on 'BIOZEPHYR' organized by

National biological for Association students (NBAS) at Chennai on 25th

Feb 2007.

> Participated in the 'LAB MEET' organized by Hi-Tech Diagnostic Centre

for NABL Standard requirements at Chennai.

> Attended Four days Training on "Laboratory Management & Internal

Quality audit Training" as per ISO 15189: 2007 (NABL) conducted by

CETE, Chennai.July 2010.

> Attended two days Training on "Laboratory Management & Internal

Quality audit Training" as per ISO 15189: 2012 (NABL) conducted by

Foundation for Quality ( India ), Chennai.NOV 2014.

[pic]

Completed projects(ISO 15189:2007) & Reference

1.Bharatscans

2.Rajmedicare Pvt Ltd,

3.Tech-med Health Centre Pvt Ltd,Chennai.

4. Dr V Seshiah Diabetes Care and Research Institute

Chennai.

Declaration

I hereby declare that the particulars given above are true to the

best of my knowledge and belief.

Date:

Yours sincerely, place: Potheri

.

(Magesh.R)

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