Summary:In this role 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 the 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.About the Role:In this role you will be required to travel up to 60% of time.Major accountabilities:- 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.- For this entry-level global auditor role, audits will typically be limited to low risk GCP/PV activities such as Investigator site audits, single service vendors, systems/process, Patient Oriented Programs, etc). Auditor may assist in supporting complex audits (Country Organizations, multiservice vendors, high risk vendors, etc).- 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 efinition 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).- Maintain current knowledge of regulations, standards, and guidance documents.Minimum Requirements:- Education: Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience).- 5 years GCP/GPvP/clinical /industry/health authority experience or equivalent (1-2 years of GCP/PV auditing experience is preferred)- Thorough knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies and procedures.- 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.- Fluent English,
at operational and functional levelDesirable requirements:- Experience with Health Authority inspections and interaction a plus.Commitment to Diversity and Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.DivisionOperationsBusiness UnitInnovative MedicinesLocationSpainSiteBarcelona Gran VíaCompany / Legal EntityES06 (FCRS = ES006) Novartis Farmacéutica, S.A.Alternative Location 1Madrid Provincial, SpainFunctional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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