Role Clarity | Executive Quality
Department: Business Excellence
Reporting To: Manager Quality (or Head Quality)
Role Definition:
The Quality Executive is responsible for ensuring consistent execution of the laboratory's Quality Management System (QMS) across assigned locations. The role supports internal audits, documentation control, data-driven analysis, and quality performance monitoring in alignment with ISO 15189, NABL standards.
Working closely with laboratory teams and operations, the role ensures audit readiness, continuous process improvement, and compliance to defined quality indicators across all functional areas.
Deliverables:
Execution of scheduled internal audits and closure of non-compliances.
Real-time maintenance and control of quality documentation and SOPs.
Ongoing monitoring of quality KPIs (e.g., TAT, rejection rate, report errors).
Actionable insights through quality data analysis and trend identification.
Timely CAPA tracking and effectiveness verification.
Operational support for audit preparedness, training, and compliance.
Responsibilities:
Internal Audit Execution
Create monthly audit calendars for assigned laboratories and collection centers.
Prepare audit tools & Checklists for pre-analytical, analytical, and post-analytical functions. Conduct surprise and scheduled audits, observing actual practices vs. SOPs.
Verify documentation of LIMS records, QC logs, equipment calibration certificates & logs, temperature & humidity logs, AMC, EQAS records, and CAPA follow-ups.
Record findings and classify non-compliances (minor/moderate/major) with supporting evidence.
Discuss audit results with Lab Manager and escalate critical gaps to Head – Quality. Follow-up with departments to ensure timely closure of audit findings with documented CAPA.
Maintain audit records, reports, and compliance tracker for review and accreditation readiness.
SOP and Document Control
Maintain a master list of SOPs with version number, review dates, and distribution status.
Assist in SOP drafting and coordinate review with relevant stakeholders (Lab Heads, Consultants).
Ensure physical SOPs are placed at points of use and are signed off by all concerned staff.
Conduct periodic reviews to verify if logs, registers, and forms are being used as per SOP.
Collect acknowledgment sheets for revised SOPs and update the SOP dissemination register.
Audit usage of operational checklists, daily QC records, and logbooks for completeness and accuracy.
Archive obsolete SOPs and documents following defined version control guidelines.
CAPA & Root Cause Management
Log non-compliances and quality incidents from audits, feedback, or process deviations.
Support laboratory teams in conducting structured Root Cause Analysis (RCA) using tools like 5-Whys/Fishbone.
Draft and circulate CAPA plans with defined actions, timelines, and responsible owners. Track CAPA implementation status weekly and send reminders to pending owners.
Review and validate closure of CAPAs with Head – Quality before documentation
Maintain CAPA tracker and ensure all records are available during audit or inspection.
Performance Monitoring & Quality KPIs:
Extract data from LIMS and other tools for KPIs - Laboratory Performacne Score, CSAT, Non Compliance, Sample Rejection Rate, Turnaround Time adherence, Report Error Rate, EQAS Scores
Analyze trends across weeks/months and identify process gaps or repeat issues.
Prepare quality dashboards/reports and submit to Head – Quality for review.
Flag areas of concern in KPI meetings and propose action points for improvement.
Coordinate with Zonal Operations/ Laboratory Heads for performance improvement initiatives.
Data Analysis and Reporting:
Verify daily recording of Key laboratory indicators such as equipment temperature, humidity, and maintenance logs.
Compile data from audit outcomes, quality deviations, EQAS results, and daily QC logs.
Perform basic analysis (counts, trends, comparison against benchmarks) and derive insights.
Maintain department-wise quality scorecards and track improvement quarter-on-quarter.
Recommend preventive quality initiatives based on recurring deviations or emerging risks.
Training & Competency Management:
Maintain training calendar for quality-related topics: SOP refreshers, CAPA process, documentation protocols.
Coordinate with HR/Training team for competency development.
Record training participation and conduct post-training assessments where required. Assist in competency validation process by ensuring required logs are filled and signed.
External Audits and Accreditation:
Assist in preparation of documentation folders for NABL audits: QMS Manual; SOPs; Audit Reports; Training Records; CAPA Logs; EQAS Summaries.
Participate in audit walkthroughs and respond to auditor queries with evidence.
Ensure audit non-compliances (if any) are closed as per agreed timelines and formats.
Maintain audit readiness at all times by conducting internal assessments and compliance checks.
