QA CSV Engineer
Walloon Brabant – Contracting
#CSV #computersystemvalidation #validation #QA #GMP #pharma
Our partner is looking for a QA CSV Engineer to reinforce its teams. Our partner is a well-known pharmaceutical industry.
What are your responsibilities?
As a QA CSV Engineer, your main tasks will be:
- Writing, reviewing and approving of validation plans and validation summary reports
- Reviewing and approving of design documentation (TCD, ERES, URS, DQ, …)
- Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
- Writing and reviewing of Periodic Review Reports (PR)
- Reviewing and approving of CSV specific documentation (inventory, …)
- Reviewing of CVS specific SOP’S and Templates
- Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems.
- Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerised systems.
- Support team and management during internal and external audits
Who are you?
You hold a degree in sciences. You have a relevant experience in validation (CSV) and you have a good knowledge of cGMP, GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, … You speak fluently French and English. You are autonomous, team player, rigorous and structured.
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marie Defruit, [email protected]