Quality Assurance Manager

1 week ago


Tembisa, Gauteng, South Africa The Aurum Institute Full time

Job Function

  • Assure compliance with laboratory accreditations, regulatory standards, and information management policies by providing leadership and guidance to employees to establish, maintain, and adhere to quality policies, processes, and procedures
  • Oversee internal audit processes, external assessments, proficiency testing programs, document control systems; competency assessment; training and other quality processes.
  • Assess the quality system's training needs and design and implement training programs accordingly.
  • Recommend best practices to maintain and improve project outcomes or laboratory functions; facilitate laboratory improvement activities.
  • Analyse and identify trends, monitor prevention and correction of quality deviations, and prepare reports for management using technical knowledge and laboratory experience.
  • Record keeping and filling in compliance with studies specific requirement and GCLP.
  • Ensure alignment of quality practices with the safety officer and security/biosecurity officer, including data analysis, trend monitoring, prevention, correction, and continuous quality improvement.
  • Implement QA related SOPs and WPGs
  • Assist in developing and managing a lab quality management plan in order to ensure the laboratory is constantly able to provide a highquality, costeffective service and correct results.
  • Monitor customer satisfaction and performance metrics.
  • Identify and report quality issues and problems to management with recommendations for resolution.
  • Establish processes and policies for effective and professional communication between laboratory staff and among other interested parties.

Education

  • Bachelor's degree or National Diploma in Biomedical Technology (NQF level 5), Bachelor of Health Sciences in Medical Laboratory Science qualification at NQF level
  • Registration with the HPCSA as a Medical Technologist or Biology Medical Laboratory scientist

Advantageous

  • Knowledge of principles of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) and International Air Transport Association (IATA)
  • Knowledge of Laboratory information management systems (LIMS) or similar laboratory information system.

Experience

  • Minimum of 5 years post qualification experience, at least 3 years of recent related laboratory work experience in a certified (e.g., GCLP requirements and experience of ISO15189 accreditation for laboratories and with 5 years in clinical research trials.
  • Equivalent combinations of directly related education and experience in quality assurance and quality management systems and quality improvement may be considered on a casebycase basis.
  • Participation or experience in audits, assessments, monitoring, and accreditation processes
  • Laboratory experience in validating and implementing new assays
  • Experience or participated audits, assessment, monitoring, and accreditation

Requirements:

  • Working knowledge of accreditation standards, practices, and guidelines sufficient to advise and guide laboratory managers and supervisors as they implement and maintain accreditation.
  • Working knowledge of computer and analytical software programs sufficient for evaluation of electronic data, data interpretation, and report development.
  • Extensive knowledge of quality management systems and quality improvement tools and techniques
  • Attention to detail, ability to work under pressure, good administration skills including report writing, work independently within mínimal supervision.
  • SA Citizen or valid Work Permit to work in South Africa
  • Driver's License
  • Own car
  • Willing to work overtime and on weekends

Closing date: 15 February 2024

Please Note:
Kindly provide current and relevant references for background checks
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