The primary role of lab quality manager will be to design and implement the lab quality management system for the diagnostic labs, in accordance with best practices followed across labs worldwide (ISO15189 /CAP/GLP guidelines)
Role and Responsibilities –
• Responsible for design & implementation of Lab quality Management System (LQMS) for all phases of lab operations-preanalytical, analytical & post analytical.
• Review IQC data – LJ chart and %CV monitoring.
• Provide guidance to lab personnel for planning appropriate Corrective ad preventive action for QC outliers evaluate Corrective actions for their effectiveness
• Ensure participation of all QMC labs in relevant EQAS programs
• Review EQAS results and assess performance of labs in Proficiency testing programs -ensure satisfactory participation
• Root Cause Analysis &CAPA for EQAS results
• Plan, organize and conduct lab and collection center audits - Internal/external ulatory audits
• Preparation and adherence to Audit calendar
• Ensure closure of audit observations within stipulated timelines
• Attaining and maintaining applicable accreditations for the lab -ensure compliance to accreditation guidelines.
• Liaison with accreditation agencies for concerns if any
• Organize Management/Lab Review Meetings at defined intervals .
• Creation and review of lab documents -Quality Manual, Quality control plan and SOPs in accordance with applicable guidelines
• Liaison with DOH to ensure continued compliance .
6 Days working schedule for 8 hours daily.
Graduate in Medical Technology with minimum 8-9 years of experience in Quality Management System.
Certification in lab quality (ISO15189 guidelines /CAP /GLP).
Need Registered Medical Technologists who have Professional Regulation Commission License ( PRC ) , also should ha
|Experience||8 - 10 Years|
|Industry||Health Care / Pharmaceuticals / Medical|
|Qualification||Professional Degree, B.Sc, Post Graduate Diploma, Other Doctorate Degree, Ph.D/Doctorate|
|Key Skills||Lab Quality Manager Medical Technology ISO15189 Lab quality Management System ISO15189 IQC data CAPA Internal Audit External Audit regulatory audits Quality Manual Quality control plan Sop Preparation DOH|
|Contact Person||Lion Sahoo|
|Address||VGP Shanti Colony|
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