Quality Assurance Specialist for Aseptic Manufacturing
6 days ago
Company Overview
Novo Nordisk A/S is a global leader in the pharmaceutical industry, committed to improving the lives of people with diabetes and other serious chronic diseases.
About the Role
We are seeking an experienced Quality Assurance Specialist to join our team in Kalundborg, Denmark. As a key member of our Aseptic Manufacturing Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.
Your Key Responsibilities
- To review batch documentation, trend reports, Standard Operating Procedures (SOPs) and deviations to ensure adherence to regulatory requirements.
- To observe performed processes and help solve issues in real-time, providing expert guidance to production teams.
- To provide quality assurance oversight during aseptic filling, identifying areas for improvement and implementing corrective actions.
- To advise stakeholders on quality-related matters, ensuring the right level of quality in production processes.
- To participate in inspections by regulatory authorities, presenting cases and demonstrating compliance with regulations.
- To contribute to process improvements in your working area, leveraging your expertise to drive excellence.
Requirements
- A Master's degree in pharmacy, medicine, microbiology, veterinary medicine or a related field.
- At least one year of experience in QA or a relevant production-related role, preferably in a regulated industry.
- Strong knowledge of Good Manufacturing Practice (GMP) and regulations.
- Excellent communication skills, with the ability to maintain a respectful tone when interacting with stakeholders.
- Proficiency in English, with good IT skills and attention to detail.
About Our Team
We are a well-functioning department with 60 engaged employees, known for our open and honest communication. We believe in continuous learning and development, and we're committed to creating a positive and inclusive work environment.
Career Development at Novo Nordisk
We offer a range of opportunities for professional growth and development, including training programs, mentorship, and career advancement. Our employees are encouraged to take ownership of their careers, exploring new challenges and developing new skills.
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