API Regulatory Specialist
3 days ago
We are seeking a seasoned Senior GMP Coordinator to join our dynamic team in API Manufacturing 4, 25K Multi Product Facilities. As a key member of our quality-focused group, you will play a pivotal role in driving quality-related improvements, audits, and inspections within our department.
Your primary responsibilities will include:
- Planning, preparing, handling, and following up on authority inspections and internal audits in 25K.
- Coordinating quality improvements in 25K and collaborating with other quality coordinators to tackle exciting tasks across the area.
- Leading GMP training and contributing to the understanding of GMP principles in 25K.
- Analyzing data to support production KPIs and driving project-based initiatives for quality process optimization.
- Filling the role as Data Integrity Steward in Novo Nordisk's Data Integrity project.
To be successful in this position, you will need:
- An academic degree in natural science, engineering, or a related field.
- A minimum of 5 years' experience in a similar role within Novo Nordisk, preferably in a GMP-regulated environment.
- Expertise in complex quality processes and experience working with Good Manufacturing Practice (GMP) regulations.
- Proficiency in English and Danish is a requirement, while experience with ISO and/or LEAN is an advantage.
As a highly motivated and solution-oriented individual, you thrive in a fast-paced environment with multiple stakeholders. Your excellent collaboration and communication skills allow you to set direction and drive results. You are proactive, systematic, and passionate about solving challenges close to the process with stakeholder involvement.
About Us
You will be part of a vibrant business area producing Active Pharmaceutical Ingredients (API) for patients worldwide. Our dynamic team at PS-API M4 is at the forefront of new initiatives, and we manufacture innovative products for diabetes, haemophilia, hormonal imbalances, and chronic diseases. With around 200 employees, we offer diverse career paths and opportunities for growth. Join us and contribute to creating life-changing medicines.
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