the-job

Validation Engineer & Analytical Development

Permanent contract

location Belgium - Braine l'Alleud

Nalys is a consulting group dedicated to high technology projects.
Thanks to our strong corporate values and adhocracy management, we are one of the fastest growing actors in engineering consultancy.
We gather great minds & challenge boundaries to help our customers develop stunning products. And we love doing it.
Discover how we can give a sense to your passion on www.nalys-group.com

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 developpment 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 pakaged 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 softwares 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, chemestry 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

Nalys 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. 

 

 

Interested ? Send us your apply