At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Diabetes poses one of today’s biggest global health challenges. We work for a future where fewer people get diabetes, everyone with diabetes is diagnosed, and everyone who is diagnosed receives adequate treatment and can live a life with as few limitations as po...
As a Quality Analyst, you will be ensuring quality assurance of outsourced and License Manufacturing of semi-finished and finished drug products. In addition, you will be conducting audits, monitoring processes, and determining the quality of outputs against defined internal or regulatory standards.
Moreover, you will ensure that retention samples received from the manufacturer meet regulatory requirements for each locally manufactured batch and that the retention samples are retained at the affiliate for the regulated time frame.
Your main accountabilities will be:
Developing and maintaining an accurate filing system for local product batch release information, reporting on process deviations and defects, and providing recommendations for improvements
Collaborating with suppliers and vendors to negotiate service-level agreements and ensure contractual obligations are met
Assessing potential risks for patients and products and offering advice and recommendations
Perform due diligence check on relevant Batch Manufacturing and Packaging Records for locally manufactured Products, according to regulatory requirements
Manage the handling of counterfeit processes for the affiliate which include logging of new cases, follow-up, and reporting of cases to the Health Authority and Global Security
Qualifications
As a Quality Analyst, you need to have continuous further education in quality assurance, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP). Nevertheless, you need to have experience in handling deviations and change requests.
To be successful in this role:
A degree in pharmacy or a relevant technical/scientific field.
A minimum of 2 years’ experience in quality assurance and production.
Experience in handling deviations and change requests.
Strong attention to detail and a quality mindset.
Proficient in prioritization and execution of activities.
Excellent communication and stakeholder management skills.
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