Advanced Quality Assurance Specialist
2 months ago
About the Role
As an Advanced Quality Assurance Specialist, you will become part of a competent team responsible for setting direction for quality and compliance due to internal and external requirements and releasing batches for the market.
Main Responsibilities
- Reviewing batch documentation, SOPs, and deviations to ensure compliance
- Assuming the role of Quality Person delegate, releasing batches after production completion
- Providing QA presence on production lines during production to observe processes and resolve issues in real-time
- Advising stakeholders to maintain the right level of quality in production processes
- Participating in and presenting cases during inspections from authorities worldwide
- Improving processes in the QA area
Qualifications
- An academic degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, or technology or biology
- 2+ years of experience in QA or a relevant GMP-related role, such as GMP Coordinator
- The ability to make decisions based on GMP knowledge and experience
- Fluency in written and spoken Danish and English
- An eye for detail, dedication, and engagement, with strong interpersonal skills
About the Department
The Biotech & Rare Disease Quality Assurance Finished Products Kalundborg department is a rapidly developing team responsible for QA for Biotech & Rare Disease packaging, producing haemophilia products and glucagon.
About Novo Nordisk
Novo Nordisk is a global workplace where passion and engagement are met with opportunities for professional and personal development. We offer a chance to be part of a truly global workplace, where you can make a difference in the lives of millions of patients living with diabetes and other chronic diseases.
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