Audit & CAPA Lead

Key responsibilities:

• Audit & CAPA process owner
• On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point of contact to adequately support the Quality & Business representatives with regards to system related questions.
• Ensure the risk-based audit strategy is properly applied, in close collaboration with the GxP Quality Leads and the Business Partners.
• Create & maintain global GxP audit programs (in line with business priorities and timelines) materialized by means of a Master Audit Plan.
• In line with the outsourced audit model, select qualified auditors to timely execute the agreed Master Audit Plan covering 3rd parties, systems, processes, studies, documents, etc… to adequately assess compliance with DPI Procedural Documents and applicable regulations.
• Manage all audit activities starting from audit planning, preparing, execution up to delivering final report.
• Contribute to preparation and conduct activities of Regulatory Authority Inspections.
• Work with GxP Quality Lead in view of adequate and timely CAPA development.
• Oversee / Manage Quality Coordinator to populate the Audit / CAPA system as per Audit / CAPA process requirements.
• Develop meaningful Audit / CAPA metrics allowing proper oversight / follow-up by business representatives (owners & department heads).
• Generate Audit / CAPA metrics to indicate areas for improvement and to drive continuous improvement initiatives.

Your profile:

• University degree: Pharmacist Diploma, PhD, master’s in science
• 5 to 8 years’ experience in managing quality assurance within the pharmaceutical industry and/or Biotech companies
• Minimum 3 years’ experience with GxP Audits
• Minimum 3 years ‘experience in managing tracking systems such as CAPAs database resulting from GxP audits (ex for GCP: CROs, TMF, Investigational Sites and CSR) as well as deviations, changes tracking systems
• Solid knowledge of GxP
• Good practical experience in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc)
• Knowledge of computerized systems validation
• Rigor, flexibility, adaptability, and organization
• Pragmatism focused on efficiency and continuous improvement
• Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities