REQ-10057165
8月 01, 2025
Italy

摘要

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 and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
Performs preparation and management of external and corporate audits and Health Authority inspections.  

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 the respect of the timeline, assess and prevent any potential interferences between projects and CAPA/Remediation plans.
  • Oversight of all production and testing activities, ensures compliance with cGxP, including data integrity and eCompliance with specific focus on Quality Workstream for the main projects on site.
  • Support exception investigations.
  • Review and approval of production, QC and AS&T records.
  • Support site qualification and validation activities (planning, advising, review).
  • Implementation of Quality Systems (incl. documentation management).
  • Supplier management activities (agreements, oversight, audit).

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Operations
Universal Hierarchy Node
Italy
Torre Annunziata
Quality
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10057165

Audit & Compliance Professional

Apply to Job
Quality Operations Italy