- Languages English
- Experience Confirmed (4-5 years)
Our client, a Worldwide Biotech leader with an Innovative products’ pipeline, is currently looking for their future QA Release Specialist on a Permanent Contract in their Headquarters.
As Release Expert, you will be responsible of releasing and disposition of batches of API’s, Drug substance, Drug products and Finished Products. You will be in charge of managing and improving the quality documentation regarding the Batch and release documentation/projects.
For this role, your main duties will be to :
- Release and dispose of API’s, DP, DS and Finished Products.
- Review and verify the batch release documentation and the Batch status.
- Perform and review the Batch release documentation regarding the Deviations, CAPA’s and change-controls with other departments to ensure that the required documentation is effective regarding the different legislations.
- Act as External Quality Expert by providing your expertise to the different stakeholders regarding regulatory and compliance questions to optimize their quality processes.
- Support the Deviations, CAPA’s and change control and revision the documentation to optimize the Product Release processes.
You profile for this opportunity :
- Bachelor / Master Degree in a scientific field (Pharmaceutical/Chemistry/Biopharma/Quality/Pharmacy, …)
- 4 Years experience on similar roles in Biotech or in Pharma industry.
- Strong knowledge of cGmP requirements and of EU and FDA Regulations.
- Fluent level of English speaking (B2), speaking German is a plus.
Feel free to apply for this opportunity if you’re looking to work on a permanent contract for a Worldwide Biotech leader company with an innovative product pipeline !
We’re waiting for your application !