Senior QP Delegate for CMC Development and Quality Assurance
3 days ago
Overview
Lundbeck is a global leader in the development of innovative treatments for brain diseases. Our clinical trials require Investigational Medicinal Product (IMP) supplies that must adhere to Good Manufacturing Practice (GMP) standards.
About the Role
We are seeking a Senior QP Delegate to join our CMC Development QA team, supporting the progression of our pipeline of promising drug candidates. As a key member of this team, you will play a significant role in ensuring patient safety and compliance with GMP regulations.
Key Responsibilities
- QP Confirmation: Confirm Biologic Bulk Drug Substance and Drug Product according to regulatory requirements.
- QP Certification: Certify IMP for clinical trials.
- QA Assessment: Conduct assessments of deviations, change controls, and laboratory deviations.
- Master Batch Records Approval: Approve master batch records to ensure compliance.
- Complaint Handling: Handle complaints related to IMP supplies.
Requirements and Qualifications
To be successful in this role, you will need:
- Strong understanding of GMP regulations and guidelines.
- Experience in quality assurance and control.
- Ability to collaborate with multiple stakeholders across CMC and regulatory affairs.
Benefits
This is an exciting opportunity to contribute to the development of innovative treatments and make a meaningful impact on patient lives. We offer a competitive salary range of $120,000 - $150,000 per year, depending on experience.
About Lundbeck
Lundbeck is a leading pharmaceutical company dedicated to improving the lives of patients affected by brain diseases. Our commitment to innovation and excellence drives us to develop life-changing treatments that address critical unmet needs.
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