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GMP Compliance Specialist
2 months ago
We are seeking a highly skilled GMP Compliance Specialist to join our team at Novo Nordisk A/S. As a key member of our Finished Production Manufacturing department, you will play a critical role in ensuring the highest standards of quality and compliance in our production processes.
Key Responsibilities- Drive the preparation and oversight of authority inspections and internal audits, ensuring seamless execution and effective follow-up.
- Coach and assist colleagues in GMP-related tasks, providing guidance and support to ensure compliance and quality excellence.
- Prepare trend reports, Quality Oversight Tools, and Quality Management Reviews (QMR) to maintain a high-level GMP overview and report on GMP and quality trends to management.
- Maintain a comprehensive understanding of GMP regulations and industry best practices, ensuring our processes remain compliant and up-to-date.
- Lead projects to success, driving process improvements and implementing effective solutions to enhance quality and efficiency.
- Bachelor's or Master's degree in a relevant field, such as pharmacy, biology, engineering, or a related discipline.
- Minimum four years of experience in process support, packaging, or QA in a regulated industry, with a strong background in GMP-regulated environments and complex production processes.
- Excellent communication and interpersonal skills, with the ability to connect with colleagues and stakeholders at all levels.
- Fluency in both Danish and English, with the ability to communicate effectively across our organization.
Novo Nordisk A/S is a global leader in the pharmaceutical industry, dedicated to improving the lives of people living with serious chronic diseases. Our Finished Production Manufacturing department is a key part of our global production network, responsible for ensuring the highest standards of quality and compliance in our production processes.
