Quality Assurance Manager, Private Institution “National Laboratory Astana”

Job description

1) Organization, implementation, maintenance and continual improvement of the Institution's quality management system; 2) Ensuring the functioning of the quality management system (hereinafter – QMS) in accordance with the requirements of ST RK ISO 15189-2023, as well as ST RK ISO/IEC 17025-2019, as applicable; 3) Monitoring laboratory activities for compliance with applicable standards, regulatory legal acts and accreditation documents; 4) Organizing the Institution's preparation for accreditation, extension of the scope of accreditation and external conformity assessments; 5) Development, updating, coordination and control of QMS documents; 6) Organizing the management of documented information, including identification, approval, updating, distribution, storage and withdrawal of obsolete documents; 7) Organizing and conducting internal QMS audits in accordance with the approved audit program; 8) Preparing internal audit plans, checklists, reports and other audit-related documents; 9) Monitoring the effectiveness of completed corrective actions; 10) Organizing risk and opportunity management within QMS processes; 11) Participating in the development and monitoring of quality indicators for laboratory processes; 12) Analyzing the results of internal audits, external assessments, quality control, complaints, nonconformities and other sources of information to identify improvement opportunities; 13) Preparing materials and reports for management review of the QMS; 14) Monitoring the implementation of decisions made based on the results of QMS management review; 15) Participating in the development and monitoring of laboratory improvement plans in accordance with QMS requirements; 16) Monitoring the availability and currency of regulatory documents, standards, methods and other documents used in laboratory activities in accordance with QMS requirements; 17) Monitoring changes in regulatory legal acts, standards and requirements of accreditation bodies; 18) Organizing employee training on QMS requirements and applicable standards; 19) Participating in personnel competence assessment with regard to QMS, biosafety and biosecurity requirements; 20) Monitoring compliance with requirements for documenting personnel competence, training and assessment; 21) Monitoring compliance with requirements for laboratory equipment management and its metrological support as part of the QMS; 22) Participating in organizing measures for quality management of laboratory test results; 23) Interacting with laboratory managers and responsible persons on the implementation and maintenance of QMS, biosafety and biosecurity requirements; 24) Participating in preparing responses to observations and nonconformities identified during external assessments and audits; 25) Maintaining established QMS documentation; 26) Preparing service notes, reports, action plans, minutes and other documents on QMS matters; 27) Providing consultation to Institution employees on the application of QMS standards and procedures; 28) Participating in the development and revision of procedures, SOPs and other documents governing laboratory activities; 29) Ensuring interaction between the Institution's structural units on quality and compliance matters; 30) Performing other assignments of the Institution's management related to the functioning and improvement of the quality management system. Higher professional education. Priority areas of specialization: - Medicine; - Laboratory diagnostics; - Quality management; - Management; - Biosafety and biosecurity. For a Master's degree, at least 2 years of experience in the relevant field; For a Bachelor's degree or Specialist degree, at least 3 years of experience in the relevant field. Experience in preparing a laboratory for accreditation and undergoing external conformity assessments is preferred. Documented training in applicable standards and requirements in the field of quality management, as well as in biosafety and biosecurity, is mandatory for performing the job duties. - Requirements of ST RK ISO 15189:2023 “Medical laboratories — Requirements for quality and competence”; - Requirements of ST RK ISO/IEC 17025:2019 “General requirements for the competence of testing and calibration laboratories” as applicable to the area of responsibility; - Requirements of ST RK ISO 19011:2019 “Guidelines for auditing management systems”; - Requirements of the legislation of the Republic of Kazakhstan in the areas of healthcare, sanitary and epidemiological well-being, technical regulation, accreditation and metrology within the scope of assigned duties; - Requirements of regulatory documents of the National Accreditation Center of the Republic of Kazakhstan; - Principles of establishing, implementing, maintaining and continually improving the quality management system; - Procedures for controlling documented information; - Procedures for managing nonconformities and corrective and preventive actions (CAPA); - Principles of risk and opportunity management; - Methods for conducting internal audits; - Procedures for analyzing the results of internal and external assessments; - Methods for monitoring quality indicators and evaluating process effectiveness; - Requirements for personnel management, competence, training and competence assessment; - Requirements for managing equipment, reagents, consumables and external suppliers as part of the QMS; - Principles for managing pre-analytical, analytical and post-analytical processes; - Fundamentals of metrological support and measurement management; - Fundamentals of laboratory testing quality management and quality control; - Principles and methods for identifying, assessing, analyzing and managing risks within the laboratory quality management system; - Fluency in Kazakh and Russian; English proficiency at no lower than Intermediate level. Fluent English is required, good command in Kazakh and/or Russian. Ability to work in a team, high level of learning ability, responsibility. PC software skills (Microsoft Windows, Microsoft Office). Recruitment and selection process Recruitment and selection at Nazarbayev University include preliminary selection based on experience and qualifications, followed by assessments and formal interviews. Formal interviews are typically based on organizational values and behaviors and conducted in English. Private Institution National Laboratory Astana The main objectives of the NLA are to conduct multidisciplinary basic and/or applied scientific research in the life sciences, energy, interdisciplinary and other fields of science, as well as activities to establish scientific laboratory, experimental bases, centers, institutes for the development and implementation of scientific, scientific and technical, educational programs and training of specialists.