Operational Quality Assurance Engineer - Life Sciences

At Assystem Care, we embrace your most complex challenges and anticipate new regulatory and technology paradigms in the life science industry. Combining compliance & performance expertise with engineering, we break silos to optimize the time-to-market. We take care of your industrial processes from strategy to operations, so that you can focus on your patients and your core business. This is our way to contribute to transforming the Life sciences industry.

Our unique advisory offer integrates end-to-end engineering, quality and performance management throughout your whole industrial life cycle, with a transverse vision of systems engineering : from conception & engineering to batch release and operations optimization. Starting from your challenges, our team of experts develops the customized solutions you need based on our methodologies and our own first-of-a-kind smart tools.

In practice, to ensure the success of your project, our experts commit on results and duration with your team, focusing on 3 core axes:

  • Compliance & Performance of your operations, supported by continuous improvement and remediations projects via proprietary approaches & technical expertise.
  • Engineering services & project management, using best-in-class risk management techniques suitable of your new and revamping industrial projects from design to validation.
  • Digital transformation, supported by data science, cybersecurity and knowledge management to secure your data and extract the needed insights for your business growth.

Our capability to integrate any solution and our systems engineering approach enable us to combine all these axes each time it is relevant.

 

To ensure the development of our activities, we are looking for a Operational Quality Assurance Engineer.

 

Your Role

 

Ensure the implementation of activities related to quality under cGMP quality systems applied within the industry:

  • Execute the gap assessment and check for anomalies and/or deviations
  • In collaboration with the production teams, determine the corrective and preventive actions (CAPA's)
  • Monitor changes via the change management process
  • Participate in the review of procedures and records (batch files)
  • Encourage critical thinking and adapt procedures or create new ones where necessary

Support the operational teams as a 'person of quality contact':

  • Participate in handling quality issues
  • Support the continuous improvement projects for quality
  • Encourage operational teams to act in accordance with statutory requirements
  • Participate in and/or run different projects with direct impact on quality

 

Your Profile

 

  • Master degree in either Engineering, Sciences (chemist, biologist ...) or Pharmacy
  • Ideally, a first experience in a regulated environment (such as food, cosmetics or pharmaceuticals)
  • A very good understanding of quality standards applicable to the pharmaceutical industry (cGMP)
  • A first experience in a Quality Assurance service is an asset
  • You speak either Dutch or French and have a good knowledge of technical English
  • You are independent, rigorous, and organised with good critical thinking

 

 

Our offer :

 

  • A salary in line with your experience
  • A competitive package of extra legal benefits (car, fuel card, insurance, meal vouchers, entertainment expenses, ...)
  • Career opportunities both in Belgium and abroad
  • Clear objectives and challenges!
  • A people focused and motivating work environment

 

It is up to you to create your own career within Assystem, with your ideas and your personality. No pathway is pre-destined; you follow the one that suits you best.