- Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements.
- Support sites in the overall regulatory inspection management. Provide expertise to sites and the global organization on GMP compliance and best practices as well as new and developing GMP regulatory requirements and trends.
- Perform Supplier Quality assessments/ audits of critical Suppliers and Contractors to annual plan and follow up on agreed upon CAPAs.
- Acts as Single Point of Contact / SPOC for assigned suppliers from a global portfolio on behalf of Head of Global Quality Compliance. Ensure the uninterrupted supply of materials and services to Lonza by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management.
- Bachelor degree in Biochemistry, Chemistry, Pharmacy, Microbiology, Biotechnology or equivalent.
- Excellent communication skills (EN / CN favorable);
- Profound knowledge in cGMPs requirements and understanding of regulatory requirement
- Proven track record with FDA, EMEA and other Health Authorities
- Extensive auditing experience, professional certifications (e.g. IRCA, PDA etc.) are desirable
- Experience in Supplier Qualification and Supplier Monitoring
- Strong understanding of risk assessment and risk management fundamentals/tools
Global Quality Compliance Auditor - Guangzhou, 中国 - Lonza
描述
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
Global Quality Compliance Auditor, you will be responsible for support the overall Lonza strategy to gain and maintain the license to operate, lowering quality and compliance risk by performing audit, advising the sites to reach an optimum state of compliance. Develop, plan and execute a program of corporate GMP compliance audits/assessments for Lonza's manufacturing sites and operations with a focus on sterile and non-sterile drug products (including solid dosage forms, biologics, cell/gene therapy), biological and chemical APIs, medical devices and excipients. This also covers food, feed and dietary supplements and sites involved in software and hardware manufacture.
Key responsibilities:
Key requirements:
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Reference: R51799