Role's Objective
Ensure the laboratory management system is established, maintained, controlled and continually improved in line with ISO/IEC 17025:2017; ensuring impartiality, confidentiality, personnel competence, document/record control, data integrity and validity of results.
Specific Responsibilities
- Establish, maintain and continuously improve the laboratory Quality Management System (QMS) in compliance with ISO/IEC 17025:2017, ensuring data integrity, confidentiality and validity of results.
- Manage the full lifecycle of QMS documents and records, ensuring proper control, traceability, storage and availability at points of use.
- Plan and conduct internal audits; manage nonconformities, complaints and CAPA, ensuring root cause analysis and timely closure.
- Oversee quality control (QC) of equipment and testing activities; ensure compliance with standards, policies and updated testing requirements.
- Support new test method development and validation, and manage Proficiency Testing (PT) activities with corrective and improvement actions.
- Provide training and coaching to staff, maintain quality awareness and manage laboratory risks (business, environmental and operational).
- Drive innovation and continuous improvement of QMS through digitalization, automation and process optimization (e-document control, dashboards, KPI reporting, Lean/5S).