Responsibilities 

  • Implement and maintain the risk-based internal and external (vendor) PV audit program, including risk strategy, tactical and operational audit planning:
  • Ensure PV audits are scheduled, conducted and reported as planned.
  • Ensure PV audit CAPAs are established, agreed and tracked to closure.
  • Ensure PV audit metrics are prepared, analyzed and improvements instituted.
  • Direct global PV inspection activities:
  • Support the Director, GVP QA in preparing all necessary departments for likely PV inspections, providing support during inspections and ensuring timely responses to inspection findings are prepared, submitted and associated CAPAs tracked to closure.
  • Oversee deviations impacting on PV: 
  • Identify and monitor deviations impacting on PV.
  • Ensure CAPA resolutions are established.
  • Verify effectiveness of the CAPA resolutions.
  • Support periodic review of PV department policies/procedures/work instructions
  • Support review of quality systems procedures from a PV QA compliance perspective.
  • Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations.
 Background:
  •  A minimum of 5 years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry, specifically within GVP auditing and with at least 3 years in quality or compliance.
  • Bachelor's or Master's degree in a scientific or life sciences discipline or equivalent.  
  • Strong working knowledge and application of global GVP regulations and guidances.  
  • Understands the regulatory environment for global pharmaceutical companies, as well as best practices to satisfy regulatory requirements.
  • Working knowledge of the pharmaceutical industry and the new drug development process. Understands the phases, processes and techniques used to execute a clinical development program.Understands the unique business requirements of operating as a marketing authorization holder in a virtual pharmaceutical environment.
  • Knowledge of and experience in quality assurance, auditing, inspection support, procedural management and quality systems (including training, deviations, corrective and preventive actions, risk management) as implemented within GVP.