QA CSV

Vacancy details

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