Summary
The Audit & Compliance Professional manages cost-effective GxP Compliance and/or Audit activities, operations, and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies, as well as all relevant GxP, legal, and regulatory requirements. This is achieved through internal audits, KPIs (Key Performance Indicators), and KQIs (Key Quality Indicators).
About the Role
Major accountabilities:
* Act as a Program/Project Manager for the Quality Stream linked to main projects at site level.
* Act as CAPA Plan and Remediation Plan Program/Project Manager, ensuring respect of timelines, and assessing and preventing potential interferences between projects and CAPA/Remediation plans.
* Oversee all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance, with a specific focus on the Quality Workstream for main projects on site.
* Support exception investigations.
* Review and approve production, QC, and AS&T records.
* Support site qualification and validation activities (planning, advising, review).
* Implement Quality Systems, including documentation management.
* Manage supplier activities (agreements, oversight, audits).
Essential requirements
• Scientific degree.
• Solid previous experience in a QA Compliance department within the pharmaceutical industry.
• Project management skills.
• Fluent in Italian and English.
Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? #J-18808-Ljbffr