Quality Assurance Officer (FTC until Nov 2021)
AJ Personnel
Mthatha, South Africa
31m ago
source : Executive Placements


Wits Health Consortium (Pty) Limited ("WHC") is a wholly-owned Company of the University of the Witwatersrand, Johannesburg (South Africa) under its Faculty of Health Sciences.

WHC provides Faculty with a legal framework within which to operate the research and other activities necessary to support its academic objectives.

In addition, WHC offers a range of products and services to the Academics conducting these activities in order to assist with the management thereof.

The Nelson Mandela Academic Clinical Research Unit (NeMACRU) is a research entity of the Nelson Mandela Academic Hospital established by the hospital in association with the Walter Sisulu University, Faculty of Health Sciences.

NeMACRU is located in one of the poorest districts (OR Tambo District Municipality) of the Eastern Cape Province. The existence of this site will not only promote excellent research output in the area but will support local health facilities with health education on vaccines and HIV Prevention.

Main purpose of the job

Manage the quality assurance of trial data and audits for the trial in order to ensure compliance with policies and procedures.


Key performance areas

  • Develop and implement a strategic quality control and safety plan in conjunction with management.
  • Perform quality assurance and control including preparation for audits and validation of methods and instrumentation.
  • Train and orientate staff in the principles of Total Quality Management and accreditation processes
  • Monitor correction of non-conformances and safety concerns.
  • Report findings and corrective measure to the Site Director.
  • Ensure the planning, control and execution of investigation and audits and the preparation of internal reports.
  • Respond to data queries from sponsors and monitors.
  • Oversee regular revision, review and updating of all documentation (policies, procedures).
  • Manage document control.
  • Generate queries log of missing required data forms and liaise with study staff regarding form tracking (e.g. weekly follow up visits).
  • Quality assurance of forms, including checking for missing data and specific edits (e.g. ensuring valid dates, etc.).
  • Give quality assured data forms to Data Capturers for entry.
  • Assist with implementation of the Clinical Quality Management Plan (CQMP) and Standard Operating Procedures (SOPs).
  • Assist with data cleaning / correction activities, including identifying and resolving database and validation errors.
  • Prepare reports on quality assurance and document management.
  • Required minimum education and training

  • National Diploma in Biomedical Technology / other relevant degree in quality management.
  • Required minimum work experience

  • 2 to 3 years experience in clinical research setting.
  • Additional education, work experience and personal abilities

  • Certification in good clinical practice (GCP) preferable.
  • Previous auditing experience will be an advantage.
  • Working knowledge of Microsoft Office.
  • Ability to function strategically with sound clinical trial knowledge and business acumen.
  • Able to exercise discretion and independent decision-making.
  • Ability to prioritise own work load and work to tight deadlines.
  • Self-motivated with a high regard for work ethic, values and integrity.
  • Overtime may be required from time to time.
  • Operate in a stressful environment as site must maintain high standards and meet donor requirements.
  • Written and verbal communication with internal and external stakeholders.
  • Presentations and reports to colleagues and management.
  • Negotiation and customer interface with external providers / sponsors and clients.

    Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV - Please Apply Online.

    Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.

    The closing date for all applications is 19 October 2020 .

    Wits Health Consortium will only respond to shortlisted candidates.

    Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.

    In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.

    Please note that AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.

    AJ Personnel does not have any salary or other information regarding the position.

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