freelance
Validation Analyst / CSV engineer Reference number: 1182
Published: 06-11-2019, 10:49
Region: Braine L'Alleud
Sector: Pharmaceutical
Job type: Medior
Job description
The CSV engineer will be part of a team composed by a project manager and technical specialists.
The project consists of moving applications from on-premise data center to the cloud (AWS).
As CSV engineer, he/she will take care about the management of all quality deliverables required and change control.
French speaker is an asset but a good level of English is mandatory.
What you’ll do
  • Write software validation deliverables
  • Manage change control
  • Risk Assessment
  • URS (with support of SMEs)
  • Validation Plan
  • Protocols
  • Test Cases (in HP ALM)
  • Manage incidents and follow-up of resolution
  • Reports
Profile
  • Experience in a pharma company would be a great asset
  • Knowledge of analytical software like Empower, Sample Management systems, ELN, OpenLab would be a great asset
  • French speaker is an asset but a good level of English is mandatory.
Required Skills
  • Be familiar with 21 CFR 11 and Eudralex Volume 4 Annex 11
  • Be familiar with Data Integrity requirements
  • At least 3 to 4 years of overall experience as a CSV analyst / engineer
  • English Fluent
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