Our client is a global Bio-Pharmaceutical company with offices in the Netherlands, Switzerland, Japan and the US. They are specialized in developing new treatments for patients with rare diseases who have few, if any, treatment options.
The Senior QA Associate will be responsible for complaint handling, product compliant investigations and the maintenance of the QMS. Furthermore, this person will help with a large serialization project and be a backup for the Associate Director QA in case of temporary absence.
- Ensure accurate and thorough complaint intake information, product compliant investigations and report/follow up the internal software QMS system (Veeva).
- Review of each complaint for missing information, further regulatory compliance or unreported adverse events
- Act as Technical SME regarding to the product
- Provide relevant Medical Device complaint information to the CMO
- Help with batch review, giving trainings, CAPA's and root cause analysis
- Set up the Quality Metrics system regarding to complaints
- Min. 3 years of experience in a QA GMP environment
- MSc. or BSc. in Pharmacy, Chemistry or Life Sciences
- Extensive knowledge of GDP and GMP
- High affinity with eQMS or software
- Experience as Project Manager is a plus
- Experience with serialization is seen as an asset
- You speak write fluent Dutch and English and/or French, German
The position is based in Utrecht with remote work in consultation.
For more information please contact Seppe Verhoeven at firstname.lastname@example.org or +32 (0) 25 881 277