Summary
The Senior Audit & Compliance Expert 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.
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Division
Operations
Business Unit
Universal Hierarchy Node
Location
Italy
Site
Torre Annunziata
Company / Legal Entity
IT08 (FCRS = IT008) Novartis Farma S.p.A.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
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