Our client a research organisation is recruiting for Head: Quality Assurance, to ensure that high quality clinical data is generated in accordance to GCP and to ensure that the trial is managed, documented and monitored within the regulatory and internal framework.
Actively lead activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audits
Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements, while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable
Ensure and maintain compliance with regulatory, ethical and GCP requirements
Initiate process improvement and Quality Document improvement activities, whilst ensuring maintenance of all quality assurance related documentation
Responsible for being a GCP expert and provide expertise and support to clinical research teams on GCP/QA questions, and interpretation of regulatory guidelines
Train research and quality assurance staff to improve data quality and be audit ready
Master’s degree in Science
Clinical Research Associate with at least 3-5 years clinical trials monitoring experience at a Clinical Research Organization
Demonstrated experience in leading a small team
Excellent understanding and demonstrated application of ICH and SA GCP and applicable Standard Operating Procedures
A broad knowledge of TB and HIV/AIDS would be advantageous
Proficiency in MS Office (Word, Excel, Outlook, and PowerPoint), project management and data analytical software
Strong technical writing skills (procedures, protocols, and reports)
You have successfully created your alert.
You will receive an email when a new job matching your criteria is posted.
Your account has not been verified. Please use the verification link sent via email.Resend Verification Link