Overview
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, through internal audits KPI (Key Performance Indicators) and KQI (Key Quality Indicators).
Performs preparation and management of external and corporate audits and Health Authority inspections.
Responsibilities
* 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, assessing and preventing 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).
Qualifications
* 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 & Experience
* 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
* Quality Assurance (QA)
* Regulatory Compliance
* Risk Management
* Self-Awareness
* Technological Expertise
Required Experience
* Senior IC
Key Skills
* Compliance Management
* Risk Management
* Financial Services
* PCI
* Banking
* Cost Accounting Standards
* Quality Systems
* Research Experience
* NIST Standards
* Securities Law
* SOX
* ISO 27000
Employment Details
* Employment Type : Full-Time
* Experience : years
* Vacancy : 1
#J-18808-Ljbffr