Novartis Farmacéutica, S.A.
Novartis Farmacéutica, S.A. Barcelona Spain
2 months ago
766! 766 million patients reached in 2021, Billion treatments supplied, 21 major approvals in US, EU, Japan and China and 3 breakthrough therapy designations by FDA only in 2021. Would you also like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?We are looking for outstanding professionals with experience as GCP/PV Auditor with a passion for quality with a patient focus. As GCP/PV Senior Auditor in Novartis, you will manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).We welcome amazing talent across Spain!This position comes with a flexible location and we are ready to hire this role in the city of preference (within Spain) of the successful... candidate.Learn more about our Technical Operations teams in Novartis: https://www.novartis.com/careers/our-teams/careers-manufacturing-supplyYour responsibilities include, but are not limited to:• Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence.• Prepare audit reports according to NVS requirements and timelines.• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures.• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP)..• Mentor junior GCP/PV staff as required
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