Gcp/Pv Auditor

hace 3 semanas


Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completo
Job Description

In this role, you will lead and support independent GCP/PV audits, ensuring compliance with Novartis Quality Systems and Standards, Good Clinical Practice (GCP)/Good Pharmacovigilance Practice (GPvP), and current GCP/PV regulations. You will provide GCP/PV related quality guidance and assist in identifying and implementing quality assurance training needs for Global GxP Audit and other business partners.

Key Responsibilities:
  • Plan, lead, conduct, document, report, and follow-up of GCP/PV audits according to Novartis procedures and applicable regulations.
  • Provide technical guidance and training on audit activities.
  • Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures.
  • Maintain current knowledge of regulations, standards, and guidance documents.
Requirements:
  • Education: Degree in natural/biological sciences or equivalent.
  • 5 years GCP/GPvP/clinical/industry/health authority experience or equivalent.
  • Thorough knowledge of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures.
  • Ability to manage and objectively evaluate compliance issues.
  • Fluent English, at operational and functional level.

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