CSV Engineer

AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in CSV.

Your responsibilities:

Quality-oriented position.
Drawing up the validation plan and reviewing the test protocols.
Drawing up periodic validation reviews (PVR) relating to computerized systems and equipment linked to computerized monitoring in accordance with regulations.
Create associated reports and review quality-related documents for final approval.
Prioritizing and analyzing SRA and Data Integrity risks according to their importance.
Check that the risks identified are being properly addressed.
Applying and reviewing CAPAs to ensure corrective and preventive action.
Participating in the CSV inventory with process control and MPU activities.
Implementing documentation in connection with Production and Quality Assurance departments.

Your profile:

You have training or certification in CSV.
A first experience in CSV position would be appreciated.
You are familiar with GMP environment and V cycle.
Knowledge of cGMP regulations, GAMP 5 guidelines, EudraLex Volume 4 Annex 11, 21 CFR Part 11.
You are able to communicate in English and French.
You are rigorous, comfortable writing and enjoy being results-oriented.

What’s the offer you can’t refuse?

As an AKKODIS Team Member, you will be:

• Onboarded in your position via a buddy process

• Supported in your career by your Business Manager

• Actor of your training plan and your personal and professional development

• Benefiting from a permanent contract

• Benefiting from a competitive salary package including several extra-legal benefits

Interested? I invite you to send me your resume to the following mail address: florent.lecoublet@akkodis.com

If you would like more information about AKKODIS Belgium and other job opportunities, please visit our website: https://www.akkodis.com/