The incumbent will:
- coordinate the activities of the Quality Assurance function in the laboratory
- design and implement Quality Management Systems in accordance with
ISO 15189:2007 standards with an intention of receiving SANAS or
equivalent Accreditation
- ensure that quality assurance standards and regulatory requirements are met
- participate in audits of laboratory operations, documents audit findings and reports results to Laboratory Management
- assist with hosting/coordinating external assessments and other inspections
- assist with and/or advises on laboratory procedure development and implementation as requested or necessary
- review, track and communicate information regarding process
variations and quality control samples as required by laboratory quality
assurance procedures
- maintain current and accurate records of all relevant communications, audits, corrective action plans
- in consultation with section heads, develop, implement and review
the Q.M.S to ensure regulatory requirements are met and test practice is
achieved
- participate in training staff to promote high quality working relationship with the laboratory
- manage validation programs for new analytical methods, critical equipment for processes
- in conjunction with Biomedical Engineering departments, prepare and
manage annual maintenance/ calibration program for equipment and
utilities including service contracts
- manage and review non-conforming events including product recall, customer complaints and internal non-conforming events
- manage archived documentation/specimen/samples
- investigate customer complaints and provide a timely response in accordance with defined procedures
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