GMP/GDP Auditor, CMC Development and Quality Assurance Specialist
2 weeks ago
GMP/GDP Auditor, CMC Development and Quality Assurance Specialist
This is an exciting opportunity for an international position as a GMP/GDP auditor in CMC Development and Quality Assurance, supporting the development of new innovative treatments for brain diseases. In this role, you will have a vital part as a lead auditor conducting external audits of CMC vendors as well as internal audits of CMC. We offer a dynamic job, auditing a broad range of vendors supplying Lundbeck ́s clinical trials from early stage to late phase including both small molecule and biologic projects.
Key Responsibilities.
- External audits of CMC vendors
- Internal audit of CMC
- Contribute to the continuous improvement of the audit process
As an auditor, you will collaborate with multiple stakeholders in CMC and vendors all over the world. You will contribute to our continued development of the Quality Management System by authoring and approving SOPs governing the activities.
Your Future Team.
You will report to the Senior Director of CMC Development QA and collaborate with peers in QA and CMC Line of Business. This is a great opportunity to impact current ways of working and improving the audit management processes.
The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US who together are responsible for efficient and compliant quality processes to support the development of Small Molecule and Biologics drug candidates including device activities. Most of our manufacturing and QC activities are outsourced to CMOs.
We offer a unique position for you to build upon your experiences and professional development. The job offers great opportunities to grow your competencies and knowledge and to widen your duties and responsibility as you develop in the role.
Requirements.
- You hold a master's degree in pharmacy, chemistry, biology or similar qualification.
- You are a trained auditor, with at least 5 years of experience as a GMP/GDP auditor.
- Fluent in English.
You like to travel as most of the audits are on site audits.
Our Promise to You.
Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.
Apply Now.
If you see yourself in this role, we want to hear from you. We encourage you to apply even if you are not sure if you meet all the requirements. Please upload your CV and include a few lines about your motivation for applying.
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