Quality Executive – Laboratory

Position Title: Quality Executive – Laboratory

Department: Quality

Reporting Manager: Quality Head

Location: Mumbai

Experience Required: 3+ Years

Industry Preference: Diagnostics / Healthcare / Pathology / Medical Technology

About Us

Redcliffe Labs is India's fastest growing omnichannel Pan India diagnostics service provider having its services in 220+ cities through a network of 80+ owned advanced labs and 2000+ Collection Centres powered by home sample collection across India. We are on a mission to provide quality healthcare services at affordable rates making diagnostics easily accessible and convenient to one and all.

Role Summary

The Quality Executive – Laboratory will be responsible for implementation, monitoring, and continual improvement of laboratory quality management systems across Redcliffe Labs. The role focuses on NABL compliance, documentation, audits, CAPA management, and quality indicators to ensure accuracy, reliability, and regulatory compliance of laboratory operations.

Key Responsibilities Quality Systems & Documentation

• Monitor and maintain quality-related matrices and records including IQC, EQAS, retest data, validation files, and other laboratory quality documents.
• Guide, support, and handhold laboratory technicians for regular and accurate filling of quality and operational documentation.
• Ensure continuity of documentation and quality processes by acting as a functional support to the laboratory team, minimizing dependency risks due to manpower changes.
• Provide operational support to the lab from a manpower and coordination perspective, ensuring uninterrupted quality documentation and compliance activities.
  
  

Quality Control & Assurance

• Perform and monitor daily Internal Quality Control (IQC) and ensure compliance with Westgard rules.
• Maintain monthly Levey–Jennings (LJ) charts and monitor Coefficient of Variation (CV%) trends.
• Manage External Quality Assurance (EQA) activities including enrollment, result submission, Z-score monitoring, and implementation of CAPA for unacceptable performance.
• Conduct Inter-Laboratory Comparison (ILC), split sample testing, and retained sample testing as per quality requirements.
  
  

Audits, CAPA & Risk Management

• Monitor, analyze, and perform trend analysis of monthly Quality Indicators.
• Plan, conduct, and review internal quality audits and ensure timely reporting.
• Ensure that non-conformities (NCs) are promptly addressed, investigated, and effectively closed.
• Ensure effective implementation and monitoring of Corrective and Preventive Actions (CAPA).
• Implement and monitor Risk Management activities including risk identification, assessment, and mitigation.
  
  

Training, Equipment & Compliance

• Handle patient complaints including root cause analysis and corrective action documentation.
• Plan, coordinate, and document staff training programs; maintain training records and competency assessments.
• Ensure preventive maintenance and calibration of equipment as per defined schedules.
• Perform and document validation and verification of equipment and Laboratory Information System (LIS).
• Ensure proper maintenance of technical log sheets and all quality-related records.
• Perform lot verification of reagents and quality control materials prior to routine use.
• Ensure compliance with Biomedical Waste (BMW) management rules and maintain related documentation.
• Maintain and periodically review Biological Reference Intervals, test methodologies, and ensure correct implementation of the NABL symbol as per NABL guidelines.
• Monitor and report Notifiable Diseases in compliance with statutory and regulatory requirements.
• Handle day-to-day non-conformances and ensure appropriate documentation and resolution.
  
  

Skills & Competencies

• Strong knowledge of NABL ISO 15189 standards and laboratory quality systems
• Understanding of pathology laboratory workflows (pre-analytical, analytical, post-analytical)
• Expertise in audits, documentation control, CAPA, and quality indicators
• Strong analytical, problem-solving, and root cause analysis skills
• High attention to detail and strong compliance orientation
• Good communication, coordination, and training skills
• Proficiency in MS Office and quality documentation tools
  
  

Key Deliverables

• NABL-compliant laboratory quality documentation and records
• Successful internal audits and timely closure of audit observations
• Effective implementation and closure of CAPAs
• Improved laboratory quality indicators and reduced non-conformances
• Audit-ready laboratories with successful accreditation outcomes
• Periodic quality reports and compliance dashboards
  
  

Preferred Profile

• Prior experience in a NABL-accredited diagnostic or pathology laboratory
• Hands-on exposure to laboratory quality systems, audits, and accreditation processes
• Certification or formal training in NABL / ISO 15189 / Quality Management Systems is an added advantage
• Ability to work independently and manage quality processes across multiple laboratories
  
  

NABL Compliance,Quality Management,CAPA Management