Computerized System Validation Specialist, Belgium - P

30 Aug 2019
29 Sep 2019
Part Time
Contract Type
Experience Level
Experienced (non-manager)
Title: Computerized Systems Validation Specialist

Location: Belgium

Schedule: Permanent/Full Time

Currently CROMSOURCE, a mid-sized international CRO, is looking for an experienced GXP Systems Validation Specialist to join our team in Belgium.

Purpose of the function:

The Computerized System Validation Specialist (CSVS) ensures that CROMSOURCE complies with applicable regulatory requirements and industry standards relating to hardware qualification and software validation and controls.

  • Edits the Validation Plan in compliance to applicable regulatory requirements and Company procedures
  • Supervises the management of Validation Plan activities
  • Performs a quality control, assuring that all the required validation documents meet all internal and external regulations/procedures to support the product release
  • Acts as a Project Manager for the internal Information Technology projects (e,g. software application) if needed.
  • Supports and guides the Computerized System Validation Associate (CSVA)
  • Performs the periodic review to the validation process in cooperation with the Quality System Manager (QSM)
  • Performs the Computerized System Validation training to all Company personnel

Job requirements:

  • University Degree in scientific disciplines
  • Three (3) years (at least) of experience in clinical research field
  • Two (2) years (at least) of experience in Computer System Validation (Clinical software service provider-eCRF, eTMF, CTMS, LIMS, ERP, ePRO, IRT, SharePoint, etc)
  • Advanced English knowledge
  • Strong knowledge of ICH-GCP/ Knowledge of software programming; performing/hosting audits
  • Strong knowledge of GAMP, FDA (e.g. 21CFR part 11; Guidance for Industry), ICH, ACDM/PSI Guidelines
  • Basic IT knowledge, expert in software development life cycle applied to GxP field; knowledge of the following software categories: ERP, IRT, CTMS, document management systems (e.g. SharePoint), eTMF, eCRF, LIMS, Microsoft office suite
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel (domestic and international)-up to 50%

Skills: Quality Assurance Manager, Computer Systems Validation Location: Belgium

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