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Validation Engineer & Analytical Development - Belgium  

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Posted on : 04 April 2017

Project Description


Description:                                 
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. 


Mission: 
  • 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: 


Operational 
  • 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  



 Quality 
  • 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  

  

About you 
  • 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  

  

About us 
  • 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.