Quality Assurance Specialist

1. Quality Assurance & Compliance:

• Ensure adherence to ISO 15189, NABL, CAP, GLP, and other regulatory standards for clinical laboratories.
• Implement Quality Management Systems (QMS) and oversee compliance with laboratory accreditation requirements.
• Conduct internal audits, risk assessments, and proficiency testing (PT/EQA/IQA).
• Develop and maintain corrective and preventive action plans (CAPA) for laboratory deviations.

2. Standard Operating Procedures (SOPs) & Process Improvement:

• Develop, review, and revise Standard Operating Procedures (SOPs) for laboratory workflows.
• Identify non-conformities and conduct root cause analysis (RCA) for laboratory errors.
• Implement Lean Six Sigma and continuous process improvement initiatives.

3. Accreditation & Certification Management:

• Prepare and coordinate NABL audits, ISO audits, and regulatory inspections.
• Ensure documentation and maintenance of laboratory licenses, certifications, and compliance reports.
• Train laboratory staff on accreditation standards and quality control procedures.

4. Equipment Validation & Laboratory Safety:

• Oversee calibration, validation, and preventive maintenance of diagnostic instruments.
• Monitor biosafety, infection control, and hazardous waste management compliance.

5. Training & Documentation:

• Conduct training programs for lab personnel on quality assurance protocols and best practices.
• Maintain detailed records of deviations, complaints, and incident reports to improve operational efficiency.