Computerized System Validation Coordinator (M/W)

ALTEN, the European leader in engineering and technology consulting, provides support for its clients’ development strategies in the fields of innovation, R&D and IT systems.

We are the reference partner for the best companies in Belgium. Located over the entire territory, we are present in the entire life cycle of the pharmaceutical product such as manufacturing, validation, QA, R&D, QC, IT and engineering.

We offer a stimulating environment that allows consultants to get involved into various projects; boosting their ability to make decisions and enabling them to create a large network.

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

At ALTEN we believe in growing together:

  • Working within a Business Unit with ambitious growth objective over 2019
  • 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, analysis positions, project manager or business management. 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. Indeed, ALTEN is present in 25 countries all around the world
  • We create an ALTEN community with several events 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
Details
Activated at 09/12/2019
Locations Belgium
Category Consultants
Contact Emma Hontang
Reference AD001438