Computerized System Validation Coordinator (M/W)

Looking for a thrilling challenge? Want to have a real impact on tomorrow’s technologies? Boost your career and join an international environment !

 

We are part of ALTEN Group, European leader in Technology Consulting and Engineering. Our 24 000 top engineers are working on various activities linked with industry, life sciences and information technologies across 20 countries around the world.

Working closely with the best companies in Belgium, we keep growing and aim to reach a 1000 consultants community in 2019.

 

If you are up to the challenge, then keep on reading, and discover the amazing opportunity below!

Tasks

As a Computerized System Validation (CSV) Coordinator, you will work within our client’s R&D or Quality Control department in order to supervise and coordinate the validation strategy in collaboration with various stakeholders (QA, QC, production). You will be in charge of:

 

  • Writing validation plans, tests and reports (URS/DQ/IQ/OQ/PQ)
  • Performing risk assessments
  • Documenting and following-up deviations and CAPAs
  • Monitoring and reviewing system documentation
  • Providing support to validation projects on infrastructure & software

Requirements

  • Graduated with a Master degree in biochemistry, bioengineering, pharmacy or related domains
  • Interest in compliance, quality issues & validation in a pharmaceutical environment
  • Experience in qualification/validation in a GMP environment and familiar with the standards and guidances (GAMP5, V-model, GxP,21 CFR part 11, Data integrity)
  • Ability to work in proficient English and French or Dutch

 Why joining ALTEN Belgium?

 

At ALTEN we believe in growing together:

  • Working within a Business Unit with ambitious growth objective over 2018
  • We involve ourselves in supporting our consultants’ career by customized follow-up and close management.
  • We can help you evolve in different directions; technical expert or into analysis positions or project manager. This is done with the support of the ALTEN Academy, that can provide you certifying trainings and tools to satisfy your thirst of knowledge.
  • We have a technical department that supports you in all your missions
  • We offer you the chance to work abroad. In fact, ALTEN is present in more than 20 countries all around the world!
  • We create an ALTEN community. Indeed, several events are organized throughout the year so that you can meet your colleagues.
  • As pioneers in innovation, we give you the opportunity to work with leading companies on the most recent technologies, in addition to an attractive salary package.

Information

Application deadline :
Contact : Florence Pinte
Region : Belgium