R.Magesh Shanthi
chief biochemist in Medilabs
Job Experience
chief biochemist
Medilabs
April 2013 to Actually working here
Existing test parameter change in other manufacture reagents before use, validation done with equipment engineer.
To help released in any abnormal test results.
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.
laboratory quality Manager
Balaji Medical centre
May 2011 to February 2013
Roles and responsibility assign to lab technician. Verify the daily internal quality control for clinical biochemistry, hematology, clinical pathology and serology. 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
Executive ?Quality Management Services.
Value Added Corporate Services (P) Ltd
September 2008 to March 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. 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.
clinical research associate (CRA)
Micro Therapeutic Research Labs Private Limited
September 2007 to 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.
Education
Master's Degree
SRM ARTS SCIENCE COLLEGE2005 to 2007
Languages
IT skills
Other Skills
More R.Magesh
Career Goals
Industries of interest
Areas of interest
Availability to travel and work outside the city
No