Quality Manager

Aurum Group

Gauteng, South Africa

12 MonthsTemporary

Jul 8

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 CoVID-19 and HIV integration.We are focused on researching, supporting and implementing integrated approaches to managing Co-VID-19 and HIV. Work DescriptionThe Quality Assurance Manager is responsible for ensuring that quality standards and procedures are met and aligned with legislation and Customer specifications through managing the Organizations quality assurance policies and controlling new product development processes. The Quality Assurance Manager is also responsible to establish performance standards, procedures and audit controls in order to meet business requirements, identify and implement process improvements to increase efficiency, effectiveness and quality of Company operations.Technical Work ResponsibilitiesProvide leadership developing and directing quality assurance (QA) for quality department by means of attention to all processes and procedures in the delivery of projectsMonitor QA systems and advise QA team on system performanceSetting up and oversight of review systems necessary to ensure high quality data collectionSetting up and oversight of regulatory systems to ensure all study documents are accurate and in accordance with ethical and regulatory procedures e.g. Investigator Site files Ensuring the accurate, timely, complete, ethical and efficient processing of study data in accordance with the study protocol, ethical and regulatory guidelines Perform gap analysis between applicable and current ICH GCP standardsEstablish and implement a quality plan to bring the company into ICH GCP compliancePerform internal QA audits that are compliant with the companys policies, practices and proceduresImplementation and evaluation of a Quality Management Program including risk analysis, verifications, validation activities and formal design reviewsPreparation of the site for external monitoring visits Development, review and implementation of protocol specific quality management plan Monitoring and reporting on quality issues to senior site managementReview of pharmacy and laboratory procedures Review of regulatory bindersMaintenance, version control and distribution of standard operating procedures and work practice guidelines bindersOversight and involvement in training of teams and individualsBack-up for the Programme Manager

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Aurum Group

We are focused on research, support and implementing integrated approaches to managing TB and HIV.