Laboratory Quality Supervisor

The Laboratory Quality Supervisor will work as part of a small team responsible for the ongoing implementation and continuous improvement of the Quality Management system, in accordance with current ISO 15189 and Good Clinical Laboratory Practice GCLP requirements, in the Clinical Laboratory of the Africa Health Research Institute AHRI - which provides clinical/diagnostic and research services for various clinical trials and research studies conducted by AHRI.
The incumbent will report to the designated Quality Manager and liaise closely with the Head of Department, Laboratory Manager, core supervisors, as well as all other laboratory team members. The incumbent will be responsible directly or indirectly for all aspects of the Quality Management System of the laboratory across all its core laboratories and sites of operation. The position is based at the AHRI Durban campus/site, but the incumbent will be required to travel to and spend time at the Somkhele campus on a regular basis.
Job Functions Chemistry, Physics and Biology,Data Analysis,Data Capturing,Laboratory Work,Other Research Development, Science and Scientific Research,Quality Control,Quality Implementation,Supervisor
Industries Ngo / Non-Profit,Research,Science &
Technology
Specification
The core functions are:
- To ensure that the quality management system is implemented and maintained in accordance with ISO 15189 requirements
- To report to and advise the laboratory management on the performance of the quality management system and needs for improvement
- To ensure that all laboratory staff are informed, adequately trained, aware of and involved in the implementation and maintenance of the quality management system
Overview of duties:
- Management of documented information in line with ISO 15189 requirements and the appropriate procedure/s of the laboratory
- Management of requirements for various audits, such as internal audits, external audits, customer audits and supplier audits, as well as risk assessments
- Management and coordination of Quality Team meetings to ensure review and timely follow up of nonconformities, customer feedback, customer surveys, quality indicators, review of documents, review and approval of documents as per schedule
- Management of Management ReviewProcedure
- Management of Equipment and Validation and environmental monitoring
- Management of Personnel Requirements
- Management of quality requirements for Clinical trials
The position is based at the AHRI Durban campus/site, but the incumbent will be required to travel to and spend time at the Somkhele campus on a regular basis.
People living with disability are encouraged to apply.
**Requirements**:
Minimum Qualifications
1. Master of Science MSc in Medical Microbiology, Virology or another related and relevant field or master-s in quality with BSc /B Tech in a Health or Science field
Minimum Experience
1. Minimum of 3 years
- experience in a diagnostic or research laboratory setting
2. Experience and knowledge operating in accordance with Good Clinical Laboratory Practice GCLP or similar environment, will be an advantage
3. Ability to write and review laboratory analytical plans and Standard Operating Procedures SOPs
4. Proven work experience as a Project Coordinator or similar role
5. Ability to prepare and interpret flowcharts, schedules and action plans
6. Familiarity with risk management and quality assurance control
Advantageous
1. SA Citizen or SA Resident with current work visa is an essential requirement
2. Solid organizational skills, including multi-tasking and time-management
3. Ability to work effectively independently and as part of a team
4. Ability to work on tight deadlines
5. Exceptional listening, verbal, written and presentation skills
6. Must be willing to work overtime as and when required