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Quality Assurance Specialist
2 months ago
Are you passionate about ensuring product excellence and compliance?
At Novo Nordisk A/S, we are looking for a dedicated QA Professional to join our Aseptic Manufacturing team in Kalundborg. This role is pivotal in maintaining the highest quality standards and adhering to regulatory guidelines.
Position Overview
In this role, you will collaborate closely with your colleagues to uphold quality assurance processes within the aseptic filling line. Your contributions will be essential in guaranteeing that our products meet rigorous standards and comply with industry regulations.
Key Responsibilities
- Review and assess batch documentation and related records from support processes, including trend reports and Standard Operating Procedures (SOPs).
- Monitor ongoing processes and provide real-time solutions to any issues that arise.
- Oversee quality assurance activities during aseptic filling operations.
- Advise stakeholders to maintain optimal quality levels throughout production.
- Participate in inspections conducted by global regulatory authorities and present relevant cases.
- Drive improvements in processes within your area of responsibility.
Qualifications
To excel in this position, you should possess:
- A Master's degree in pharmacy, medicine, microbiology, veterinary medicine, or a related field.
- A minimum of one year of experience in quality assurance or a similar production-related role.
- Familiarity with Good Manufacturing Practice (GMP) and relevant regulations.
- Excellent communication skills, fostering respectful interactions with stakeholders.
- Proficiency in both Danish and English, along with strong IT capabilities.
As an individual, you should have a meticulous attention to detail and a proactive approach. Your ability to build strong relationships with stakeholders will make you a valuable member of our team.
About Our Department
The Aseptic Manufacturing Quality Assurance team in Kalundborg is a cohesive unit with numerous interactions across the organization, including production, management, and other QA departments. Our team consists of 60 committed professionals who thrive on open communication and collaboration. We embrace challenges and take pride in our ability to work independently while contributing to a supportive work environment.
Our primary mission is to establish and uphold the quality standards of our production area, directly impacting the products delivered to patients worldwide. The QA role is crucial in ensuring that our production processes consistently comply with both internal and external guidelines.
