Head: Quality Assurance

SUMMARY:
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POSITION INFO:

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)

If you meet all of the above, please send your CV to hr@pronel.co.za Please note due to high volume responses, only candidates that meet the advertised criteria will be contacted.

NB! This job is now closed. You can apply for other jobs by uploading your CV.