30+ different sterile products, 120+ countries supplied with our products. As a postgraduate in the QA Compliance department, you provide expert support in the areas of inspection management, compliance and implementation of the Novartis Quality Management System to ensure all activities related to both site and product are compliant with cGxP requirements (incl. data integrity), Novartis internal quality standards, and relevant international and local regulatory requirements.
Fluent German and English skills are required for this position.
Your responsibilities include but are not limited to:
• Ensure all activities are in compliance with cGxP, incl. data integrity
• Support with the preparation of Annual Product Quality Review activities according to Novartis procedure
• Support with Third Party management activities
• Support with the implementation of Quality Systems
• Participate in on-site HA inspections and customer audits
• Support with continuous improvement projects within the QA compliance department
• Support with CAPA tracking and assisting, reporting and reviewing of QA department metrics e.g. Monthly quality report, KPI reports.
• Collaborate with cross-functional teams within manufacturing and Quality Management
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Whatyou'll bring to the role:
• BSC or MSc Graduate in Chemistry, Pharmacy, Microbiology, Biotechnology or related science (degree completed within the past 12 months)
• Knowledge of current GMP and Regulatory guidelines (ICH, FDA, EMA)
• Experience in pharmaceutical manufacturing site and/or QA/QC is beneficial
• Strong communication and negotiation skills, excellent time and self-management
• Knowledge of GMP Auditing processes preferable
• Proficient English (spoken & written) and fluent German (spoken & written)
743 million. That's how many lives our products touched in 2022, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!