Qualified Person, European Union
Have you ever wanted to be a pioneer in the Life Science industry? Have you ever wanted to be a part of something truly extraordinary in an innovative and ground-breaking biotechnology company? 2020 is going to be a year that will propel this already Global Biotech to one of the industry-leading companies in its field in the fight to cure diseases.
They are looking to recruiting a passionate individual to become a new Qualified Person for the European Union at their European Head-Quarters in the South Holland province of the Netherlands. If you are a registered Qualified Person or have ever wanted to become a Qualified Person, we want to speak to you. Full, immediate, training will be given to the successful candidate to release medical products for patients across the European Union.
You will be a primary Quality contact in Europe for the Global QA group who operate in North America and Far-East Asia. You will also liaise with regulatory agencies (FDA, EMA) and regularly conduct site-inspections. You will be responsible for the release of parental biopharmaceutical products for investigational products (phase I-III) and medicinal products in accordance with regulatory authorisations, EU regulatory requirements, applicable quality agreements, and commercial agreements with my clients marketing partners. They are developing medicines focused on immunology, oncology, and metabolic diseases.
Responsibilities:
- Lead regulatory inspections and responsible for the regular update and revision of MIA Licence
- Assure all products manufactured by my client and third-party contractors fully comply with cGMP regulations
- Assure as EU QP all products of insufficient or dubious safety, quality and/or efficacy are not distrusted
Requirements:
- +4 years Quality Assurance Experience
- Last 2 years of employment in a pharmaceutical manufacturing/production facility
- Thorough understanding of Good Manufacturing Practice's
- Fluent in English
Package:
- Non QP candidates: starting from 70,000 - 80,000, depending on candidate experience
- Registered EU QP Candidates: starting from 80,000 - 90,000 depending on candidate experience
- KPI Bonus
- Relocation support
- Training to become a registered QP to release biopharmaceutical products to the EU market
Apply:
Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: or phone +44203758831
