Gcp/Pv Auditor

hace 2 semanas

Madrid, Madrid, España Novartis Farmacéutica A tiempo completo

About the Role

In this position, you will lead, support, and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the 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 the identification and implementation of quality assurance training needs for Global GxP Audit and other business partners.

The audits performed on behalf of Global GxP Audit include all audit types across GCP and PV disciplines, including internal and external targets. You will be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards.

Key Responsibilities

Plan, lead, conduct, document, report, and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.

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.

Maintain current knowledge of regulations, standards, and guidance documents. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).

Requirements

Education: Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience).

Experience: 5 years GCP/GPvP/clinical/industry/health authority experience or equivalent (1-2 years of GCP/PV auditing experience is preferred).

Knowledge: Thorough knowledge of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures. Skills: Ability to manage and objectively evaluate compliance issues. Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving. Experience with Health Authority inspections and interaction is a plus.

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