|Publication date:||March 23 2021|
Since the founding in 1978 as one of the world’s first global biotechnology companies, this organisation has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases. This organisation is looking for an EU Qualified Person. Millions of people around the world are affected by multiple sclerosis, Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Many people also suffer from less common diseases such as spinal muscular atrophy (SMA) and progressive supranuclear palsy (PSP). They believe that no other disease area holds as much need or as much promise for medical breakthroughs as neuroscience.
This leading Biotech organisation has some of the world’s best neurologists and neuroscientists. They engage with physicians and scientific leaders around the world with the aim to further medical research. Their focus on neuroscience, their deep scientific expertise and their courage to take risks make them leaders in the research and development of medicines to transform neuroscience to benefit society. This organisation is committed to their employees, diversity and inclusion, and environmental sustainability and care deeply about making a difference.
For the site in the area of Amsterdam, we’re looking for an EU Qualified Person. It will be your responsibility to act as Qualified Person (QP) responsible for the certification of Finished Goods within the European Union (EU) of medicinal products for human use holding a Marketing Authorization (MA) or made for export as per European Directive 2001/83/EC, 2017/1572 as well as delegated regulation 2017/1569. You will be responsible for batch certification of commercial and clinical finished products for the EU and rest of the world following respectively Annex 16 and 13 of EU regulation.
The biggest part of the responsibilities will be EU QP batch certification as per Annex 16 and 13. This will include:
We’re looking for a candidate with:
In return for your work, the organisation can offer the following:
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Principal Consultant | Biotech & Pharma