Global GCP/PV Senior Auditor

Sep 10, 2021

Job Description

Global Senior GCP/PV Auditor

How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?

As Global Senior GCP/PV Auditor, you will be responsible for leading, supporting and reporting independent GCP and PV audits and approving follow-up CAPAs according to Novartis guidelines and GCP regulations.

Your responsibilities include, but not limited to:
• Supporting the strategic development of an effective global risk-based audit strategy and programme; collecting, collating and incorporating input into audit strategy and plan
• Leading, planning, conducting, documenting and following-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. Performing activities with a high degree of independence
• Providing technical guidance, leadership, mentoring and training of other auditors on audit related activities
• Assessing the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
• Identifying and communicating quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommending remediation
• Leading compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement as requested
• Proactively researching local and global initiatives, trends and events that impact maintenance of compliance
• Maintaining current knowledge of regulations, standards, and guidance documents

Minimum Requirements

Novartis Technical Operations
Full Time

Global GCP/PV Senior Auditor

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