Gcp/Pv Audit Specialist
hace 4 semanas
This role with Novartis focuses on leading and supporting GCP/PV audits to ensure compliance with quality systems and standards. You will provide guidance on GCP/PV related quality issues and assist in identifying and implementing quality assurance training needs.
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 of critical audit findings and support immediate follow-up measures.
Requirements:
- 5 years of experience in GCP/GPvP/clinical/industry/health authority, with GCP/PV auditing experience preferred.
- Thorough knowledge of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures.
- Ability to manage and objectively evaluate compliance issues.
About Novartis:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We pursue amazing talent across Spain and offer a flexible location for this role.
This position comes with a flexible location and we are ready to hire this role in the city of preference of the successful candidate. The audits performed on behalf of Global GxP Audit include all audit types across GCP and PV disciplines including internal and external targets.
Auditor may assist in supporting complex audits. 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 according to the Novartis requirements on Management Escalations and other relevant procedures.
Ensure adequate definition and recording of mitigation plans when applicable. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
This role requires a thorough knowledge of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures. You will be required to travel up to 60% of the time. We are an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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