Manager Quality

Role Definition:

The Quality Manager is responsible for developing, implementing, and maintaining the laboratory's quality management system. This role ensures compliance with national quality standards, oversees quality control and assurance programs, manages regulatory requirements, and fosters a culture of continuous improvement within the laboratory.

The Quality Manager works closely with Consultants, Department heads, and business teams to maintain high-quality laboratory operations and enhance patient satisfaction.

Deliverables:

Quality Management System in compliance with ISO 15189 NABL and CRO standards

CAPA implementation

Standard Operating Procedures (SOPs)

Training programs

Quality performance metrics and audit outcomes.

Resolutions for customer feedback and complaints.

Responsibilities:

Quality Management:

Develop, implement, and maintain the laboratory's quality management system. Ensure compliance with national quality standards (e.g., ISO 15189 NABL, CRO). Ensure the laboratory complies with all relevant regulatory requirements and guidelines.

Execute the implementation of QC and QA programs. Check and document the performance of QC materials.Review QC results from the previous day, including: Verify control charts and trends, Identify any outliers or deviations., Investigate root causes of any anomalies.

Ensure all equipment calibration records are up to date. Schedule and verify preventive maintenance tasks. Ensure that environmental conditions (temperature, humidity) are within specified limits.

Review QC results of Laboratory and ensure any anomalies are addressed immediately by Department Heads and Consultant. Monitor laboratory processes to ensure they meet quality standards.

Prepare for and manage internal and external audits. Conduct regular internal audits to ensure compliance with QMS. Review audit schedules and plans. Ensure all required documentation is ready for upcoming audits. Address any findings from previous audits.

Ensuring CAPA with the Business Team

Review and analyze QC data to identify trends and areas for improvement. Lead the audit process and implement recommendations from audit findings.

Log and review all non-conformities.Conduct root cause analysis for recurring issues.Implement corrective and preventive actions (CAPA) for any identified issues.

Develop and track CAPA action plans to address identified issues. Regularly monitor the effectiveness of implemented CAPA measures. Maintain detailed records of CAPA activities and outcomes.

Collaborate with business teams to identify root causes of non-conformities and implement corrective and preventive actions and ensure quality standards are met across all laboratory functions.

Standard Operating Procedures (SOPs):

Develop, review, and update SOPs for all laboratory processes.

Verify that all laboratory logs are properly filled and signed off. Ensuring all documentation is up-to-date and processes are compliant through regular audits.

Ensure all staff are trained on and adhere to SOPs.

Manage the creation, review, approval, and archiving of quality-related documents.

Training and Competency:

Develop and implement training programs for laboratory team members. Evaluate the effectiveness of training programs. Update training materials as necessary.

Assess and ensure team members competency in performing laboratory tasks.

Customer Feedback and Complaint Management:

Manage the customer feedback and grievance system.

Investigate and resolve issues, ensuring customer satisfaction and quality improvement.

Address and resolve any quality-related complaints from customers.

Quality Metrics and Reporting:

Develop and monitor key performance indicators (KPIs) related to quality.

Analyze quality data to identify trends, root causes of issues, and opportunities for improvement. Use data to drive decisions related to quality improvements.

Report on quality performance to senior management.

Organize and lead quality meetings to discuss performance and improvement opportunities.

Success Metrics:

Successful completion of External audits with zero major & moderate non-conformities.

20% reduction of Repeated Non Compliances every month

Zero Detractors by the end of Qtr

95% of audit findings resolved within 30 Days

95% CAPA action plans implemented within agreed timelines.

98% achievement of key performance indicators (KPIs) related to quality, such as turnaround time, report error rates, and customer satisfaction scores.

100% of SOPs reviewed and updated annually

Zero missing documents during external audits