Quality Assurance Manager

Job Description

Main job responsibilities of Quality Manager are as follows for both central lab & satellite labs (but not limited to): 1. Quality Assurance System Implementation Ensure the implementation, monitoring, and control of QMS across all diagnostic centres as per ISO/NABL/CAP standards. Responsible for drafting, reviewing, issuing, and updating quality documents including Quality Manuals, SOPs, QMS Procedures, forms, and flowcharts. Monitor compliance and initiate corrective/preventive actions for non-conformities. 2. Accreditation & Audit Management Manage the accreditation lifecycle for NABL & CAP, including applications, reassessments, and documentation of correspondences. Coordinate and face internal and external audits; document and track audit findings, NCs, and ensure closure within timelines. Maintain updated accreditation certificates and display them at all centres. 3. Internal Audits & Management Reviews Plan and conduct periodic internal audits across departments and centres (including reception, phlebotomy, sample receiving, housekeeping, etc.). Organize Management Review Meetings (MRM), prepare MOMs, follow-up on decisions and ensure documentation. Organize safety audits, mock drills, and other quality meetings with documented outcomes. 4. Document Control Maintain a central document control system for all quality documents. Ensure timely revision, issuance, withdrawal, and obsolescence marking of documents and SOPs. 5. Complaint Handling & Incident Management Manage all customer complaints for the central lab and ensure timely investigation, closure, and documentation in complaint logs. Maintain incident/accident records (e.g., needle-stick injuries, spillages) for all centres. 6. Equipment & Calibration Management Prepare calibration and preventive maintenance schedules for all analyzers and equipment. Ensure IQ/OQ/PQ documentation for new instruments and proper documentation of PM and calibration activities. Maintain equipment breakdown logs and ensure regular internal calibration of centrifuges (bi-annually). 7. External Quality Assurance (EQAS)/Proficiency Testing (PT) Oversee all EQAS/PT activities: registration, timely testing, result documentation, and corrective actions for unsatisfactory results. Coordinate root cause analysis and maintain EQAS/PT records as per CAP/NABL requirements. 8. Training & Competency Identify training needs, prepare training plans and materials, and conduct induction and periodic staff training. Collaborate with HR for onboarding lab tours and maintaining training records. Evaluate training effectiveness, especially for new phlebotomists and technical staff. 9. Quality Indicators & Statistical Analysis Define quality indicators and statistically analyze performance every 6 months month. Present quality trends and improvement initiatives in monthly/quarterly lab presentations. 10. Other Responsibilities Ensure proper functioning of the lab's water treatment system. Maintain patient unclear prescription files. Ensure immunization status is updated for all employees. Participate in DSIR approval processes and ethical committee meetings. Maintain various logs and registers including reagent storage, report delay logs, PT records, and doctor rosters. Prepare SOPs for new tests and contribute as CAP Section Director for Lab General Checklist audits. Prepare monthly LAB PPTs and CAP PT survey forms.