- Languages English
- Experience Junior (1-3 years)
Our client, a Worldwide Biotech leader with an innovative products pipeline, is currently looking for its future External Quality Release Specialist on a permanent contract !
For this role, your main duties will be to :
– Review the batch release documentation regarding the local procedures and market targeted.
– Follow and manage the deviations, change control and CAPA’s related to Batch review and release documentation.
– 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 legislation.
– Participate in the drafting of the Annual Product Review (APR) for the release and the Batch Record Review processes.
– Evaluate the CMO’s regarding their batch Record Review processes.
– Collect the missing information/documents from CMO’s.
Your profile for this opportunity :
– Bachelor / Master / PhD Degree in a scientific field (Pharmacy/Pharmaceutical/Chemistry/Biopharma/..)
– 3 Years’ experience on similar roles in Biotech or in Pharma industry.
– Strong knowledge of cGMP, GDP and EU/FDA regulations.
– Fluent level of English speaking (B2), German is a plus.
Il you are interested to work on challenging projects for an innovative Biotech leader company, do not hesitate to apply for this open opportunity, our client is waiting for you !