General information
Reference
2023-29562
Publication date
17/11/2023
Position description
Category
OPERATIONS - CONSULTING
Job title
QA CSV
Contract
Permanent contract
Contractual hours
Full time
Job description
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.
Business Industry
Life sciences
Profile
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.
Position location
Job location
Europe, Belgium, Wallonia, Walloon Brabant
Location
Avenue Jules Bordet 168 1140 Bruxelles
Candidate criteria
Level of experience
3 to 5 years