Vacancy QA GDP Specialist (Responsible Person) – Naarden
The company is a leading global player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) and is looking for a QA/PV Manager. The company has a significant presence in branded generics markets across emerging economies. The organisation has a fast growing and robust EU and US generics business and sales operations in over 95 countries. The subsidiary also markets APIs to regulated and semi-regulated countries.
In this role, you will be responsible for ensuring compliance to EU Good Distribution Practices, Quality Assurance requirements.
You will be acting as the key interface between the regional Quality / Pharmacovigilance / Regulatory Affairs functions and the local business, ensuring appropriate communication within the local business. This position will assume the role of LPVRP and RP.
One of the main responsibilities in the role is the reviewing of batch records and the review of temperature and humidity data. You will be working closely with Supply Chain manufacturers and support in the management, further development and optimisation of the local quality system as part of the European QMS. Finally, in this role, you will be the acting responsible person (RP).
We’re looking for a candidate with:
- Life Sciences degree or equivalent
- Previous experience in a similar Quality and/or PV / device vigilance role within a Pharma or Medical Devices environment
- Previous experience in Pharmaceutical or Medical Devices distribution quality environment with knowledge of GDP and warehousing/customer service experience
- Basic knowledge of the Pharmaceutical wholesale or manufacturing quality environment with knowledge of GMP and production experience (desirable)
- Auditing experience (not essential)
- Fluent in English and Dutch
- Understanding of regulatory requirements and specifics in the Netherlands
The company offers a competitive package with 30 holidays and a bonus plan up to 15%.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Principal Consultant | Biotech & Pharma