The Aurum Institute is offering a great opportunity to suitably qualified and experienced staff to contribute towards our mission to improve the health of people and communities through innovation in Health Research and Systems. We are focused on research, support and implementing integrated approaches to managing TB and HIV. The following positions have become available as part of the various projects currently being run by us and you are welcome to apply should you meet the requirements of the position. Work DescriptionThe Quality Assurance Officer is responsible for conducting, implementing and managing all quality assurance related activities including managing the review systems facilitating the collection of quality data. The Quality Assurance Officer oversees that all processes contributing to the performance of a clinical trial are conducted in compliance with the applicable regulatory requirements, protocols, ICH GCP Guidelines and South African Guidelines.Technical WorkImplement quality assurance standards Evaluate adequacy of internal quality assurance standardsDevelop sampling procedures for recording and reporting quality dataReview the efficiency of quality and inspection systemsDocument internal audits and other quality assurance activitiesInvestigate and resolve all non-conformance issuesCollect and compile quality statistical dataAnalyse data and identify areas for improvement in the quality systemDevelop, recommend and monitor corrective and preventive actionsPrepare reports to communicate the outcome of all quality activitiesIdentify training needs and schedule training interventions to address the requirements for all quality standards Coordinate and support on-site audits conducted by external providersEvaluate audit findings and implement appropriate corrective actionsMonitor risk management activitiesOversee document management systemsComply with all quality and industry regulatory requirementsDutiesLiaise with all internal and external stakeholders when necessary towards the achievement of the company and divisional goalsInform all role players of any new and/or revised regulations Oversee that regulatory rules are communicated through the organisations policies and proceduresCommunicate any critical compliance risks to senior managementConduct in-house compliance monitoring in adherence to ICH GCP guidelines, relevant standards, protocols and regulations Data verification of source data from relevant documents e.g. CRFs and other data collection formsMaintain the data bases for the quality management system Preparation of annual reports and quality trending reportsReview corrective and preventative actionsProvide feedback on findings and trends Conduct quality control checks on source documentationRaise study related queries with the QA Manager, Principal Investigator, Project Manager and Study Coordinator to enable clean and accurate dataReview project source documentationProvide training on quality related topicsPrepare for monitoring auditsSOP/WPG review and development as required Support the QA Manager in implementing the Quality Management Plan/ProgrammeKnowledge of all relevant legislation, compliance trends and issuesManage the version control of study documents Timely reporting of all project activities utilizing predefined indicators Perform quality control on recording and reporting procedures Document internal regulatory processesMaintain favourable relations with cross functional teams Provide leadership and strategy in line with global standards Identify training needs and inform the relevant Study Coordinator/Project ManagerComply with all safety policies, practices and procedures according to prescribed legislationReport all unsafe activities to Senior Management/Human ResourcesParticipate in proactive team efforts to achieve departmental and company goals
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