Vacancy Qualified Person – Amsterdam
Pioneers in neuroscience!
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. 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 makes 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 a 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 well as delegated regulation 2017/1569. You will be responsible for batch certification of commercial and clinical finished product 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:
- Perform EU QP certification for all products under Biogen responsibility including partners products.
- The QP certifying the finished product is responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing Authorization), and the MA (Marketing Authorisations).
- Ensure Quality Assurance related Compliance with all National and International Regulations of the Authorities and internal regulations.
- Focusing on the Management of authorised activities and the accuracy and quality of records.
- Review and approve Product Quality Reviews (PQR/APR)
- Certification is recorded in a register or equivalent document.
- Ensure that at minimum one deputy QP is in place to perform EU QP Certification; ensure the deputy QP has the necessary experience and education required.
- Ensure maintenance of supply to the market
- Furthermore you will be responsible for:
- Different stages of manufacturing
- Manufacturing license maintenance
- Complaints and recalls
- Marketing authorization filing currency and support
- Manage the Delegate QP team
We’re looking for a candidate with:
- MSc in Industrial Pharmaceutical Science or similar course recognised by Regulatory Authority
- Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
- Third level qualification in a science discipline
- A minimum of 8 years experience in the healthcare / pharmaceutical industry gained in a FDA and EMA approved pharmaceutical environment.
- Experience as a QP from biotech or pharmaceutical industry.
- Proven knowledge of AMG 2017
- Leadership skills
- Ability to cope well under pressure, make confident judgements and act decisively when things go wrong
- Strong understanding of the manufacture and supply chain
In return for your work, the organisation can offer the following:
- Being part of a stable and fast growing organisation
- An environment that is dynamic, offering you room to develop many different skills and providing your own input in the development of processes
- Excellent personal and growth opportunities
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Principal Associate | Biotech & Pharma