**Summary**:
Supports 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). -Supports the preparation and management of external and corporate audits and Health Authority inspections
**About the Role**:
**Major accountabilities**:
- Planning and supporting PQR/APQR activities
- Support site qualification and validation activities (planning, advising, review)
- Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit)
- Preparation/support and coordination of CAPA/follow-up
- Audit and inspection preparation and support
- Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc...