Validation Engineer & Analytical Development - Belgium
We gather great minds & challenge boundaries to help our customers developing stunning products. And we love doing it.
About the job
- You will be part of a global project whose objective is focusing on development and production of treatments for severe diseases, particularly in the field of central nervous system, inflammatory disorders and oncology.
- Working for the Global Quality Assurance Department, you will join a team of experts dedicated to maintaining a high level and harmonization in QA processes.
- You will join a team working on the development and the validation of analytical methods for quality control of medication.
- You will participate in the release and stability analyses of raw materials, intermediates, drug substances or drug products.
- Your next challenge will include the following responsibilities:
- Develop and validate analytical methods to support projects in development in different phases of product development.
- Perform analyses of raw materials, intermediate products, in bulk or packaged finished products in accordance with work instructions and established procedures (stabilities, in-process control, clinical release, investigation, ...).
- Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in support to process understanding (IPC test, forced degradation study, multimedia dissolution, ...)
- Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
- Participate to analytical exercise transfer to QC and subcontractors.
- Monitor the documentation associated with the analytical laboratory activities by mastering the computer software's in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, ...).
- Read and Write in English
- Make sure to have received and understood all the information and instructions required for the tasks before starting work.
- Respects the procedures and reports any discrepancies to the responsible
- Use authorized and validated methods prior to testing, if applicable.
- Respect and properly maintain the analytical equipment and facilities at disposal.
- Performs double check the team
- You hold a Master degree in Pharmaceutical, chemistry or related studies
- You have at least 2 years’ experience in a similar role
- You are fluent in French and you are able to read & write scientific document in English
- Corporate values mean a lot for us. We expect them to mean something for you
- Our company is a people company. We will give you the opportunity to challenge yourself while doing something you love.
- So whether you are a creative, a dreamer or an achiever, you can find a way to do something you truly enjoy.
- And because we want our company values to be more than words, we invest 7% of our annual revenue to drive innovation, develop your expertise, train your brains and give you time & tools to think big.