Job Description 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 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.
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.
Skills Desired
Auditing
Audit Management
Communication Skills
Compliance Audits
Compliance Risk
Continued Learning
Dealing With Ambiguity
Decision Making Skills
Gmp Procedures
Inspection Readiness
Organizational Skills
People Management and Leadership
Qa (Quality Assurance)
Regulatory Compliance
Risk Management
Self-Awareness
Technological Expertise
Required Experience
Unclear Seniority
Key Skills
Abinitio
Apprentice
Dermatology
Cost Estimation
Data Networking
Liaison
Employment Type:
Full-Time
Experience:
years
Vacancy:
1
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📌 Audit & Compliance Professional
🏢 Novartis
📍 Torre Annunziata