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.
Required Skillsets-
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
No. of Openings : 1
Education : Professional Degree, B.Sc, Post Graduate Diploma, Any Doctorate Degree, Ph.D/Doctorate
Role : Lab Quality Manager
Industry Type : Hospitals / Medical / Healthcare Equipments
Gender : [ Male / Female ]