Safeguard that all site and product-related activities meet cGxP requirements including data integrity, Novartis quality standards, and applicable international and local regulations
Job Summary
Safeguard that all site and product-related activities meet cGxP requirements including data integrity, Novartis quality standards, and applicable international and local regulations.
Act as a site subject-matter expert in your designated area such as data integrity, audit and inspection management, deviation investigations partnering closely with Manufacturing, QC laboratories, MS & T, Supply Chain, QA departments and external partners.
Through your contributions to investigations, CAPAs, audits and inspections, and continuous improvement, you will strengthen compliance, make a meaningful impact across our operations and for the people relying on our medicines.
Matching Summary
Safeguard that all site and product-related activities meet cGxP requirements including data integrity, Novartis quality standards, and applicable international and local regulations.
Skills & Requirements
Must-have
cGxP requirements
Novartis Quality Management System
data integrity
audit and inspection management
deviation investigations
CAPAs
Nice-to-have
collaboration
dealing with ambiguity
digital savviness
leadership
problem solving skills
Key Requirements
Master’s degree in a scientific field
Experience in a regulated environment
Strong understanding of Good Manufacturing Practices