QA CSV

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

Your responsibilities:

As part of the QA department, your role will be to implement and ensure the effectiveness of the quality system.
Set up Data Integrity Risk Assessment (DIRA) for all computerized and automated systems.
Check maintenance of qualified/verified status for computerized and automated systems.
Interpret analysis linked to change requests.
Contributing to and review the application of an audit trail review strategy.

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.
Compliance with regulations as cGMP, 21 CFR Part 11 and EudraLex Volume 4 Annex 11.
Knowledge of GAMP5 and GxP systems guidelines.
You are able to communicate in English and French.
You are rigorous, comfortable writing and enjoy being results-oriented.