About the Company:
TASK Applied Science performs clinical trials in tuberculosis (TB) in Cape Town, South Africa. The high incidence of tuberculosis in our region illustrates the great need for better diagnostic tests and more effective treatments for TB. TASK provides assistance to efficiently conduct studies for diagnosis, treatment or prevention of Tuberculosis.
The Quality Assurance Operations Manager (QAOM) works closely with the QA Line Manager who both reports to the QA Head. The QAOM is responsible to manage the TASK Quality Assurance department’s day to day operations to ensure QA functions optimal. The QAOM ensures that the clinical quality management plan (CQMP) including the monitoring tools used are functional and current by performing an annual review on all CQMP’s.
The QAOM also works closely with the Quality Assurance Coordinator (QAC), offering support within the team and to sites as needed. The QAOM receives the monthly QA reports, sponsor and audit reports and prepares 6 monthly QA progress reports for review by QA Head and feedback to company on overall TASK QA/QC performance.
The QAM is responsible to ensure that all clinical relevant equipment is serviced and/or calibrated as well as maintain a system to control, replace, receive and distribute equipment between sites to ensure reliable data is reported.
Assist in the drafting and implementation of SOP’s and a staff training as well as induction program for external and internal training modules. Ensures the training system is maintained and distribute training as well as SOP’s in accordance with GCP document control.
The QAOM may together with the QALM / QA Head conduct internal QA reviews / audits periodically and report on it.