API Quality Assurance Specialist
1 month ago
We are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team at Novo Nordisk A/S.
The successful candidate will support CMC API Development within the raw material and Contract Manufacturer (CMO) shipping area. This role is responsible for ensuring compliance with regulatory requirements, quality standards, and company policies.
You will be part of our development projects, ensuring that raw materials for our products are used in clinical trials following the information provided to Health Authorities worldwide. Furthermore, you will identify and contribute to strengthening our production facilities' compliance level if needed and act as a consultant for stakeholders.
This position requires delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials. Key responsibilities include challenging and approving documents related to raw materials and CMO shipping, participating in regulatory inspections and audits, and securing quality agreements with external suppliers.
To succeed in this role, you have:
- A Master's degree in Pharmaceutical Sciences, Engineering, Biochemistry, or similar field.
- At least one year of experience from the pharmaceutical industry within quality or production.
- Experience with Good Manufacturing Practice (GMP).
- Experience working with raw materials for API production.
- Proficiency in English.
The salary range for this position is approximately €60,000 - €80,000 per annum, depending on your qualifications and experience. Additionally, you can expect excellent benefits, including a comprehensive pension plan, flexible work arrangements, and opportunities for professional growth and development.
Candidates who thrive in this role are self-driven and independent individuals with a high sense of responsibility and initiative. You must be able to prioritize multiple tasks and work effectively in a dynamic environment where teamwork is essential. If you have a well-developed understanding of quality and a natural ability to handle quality issues, we encourage you to apply for this exciting opportunity.
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