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CSV Compliance Officer - Brussels region - 12 months

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ID de l'emploi:

3265316

Lieu:

, , Belgique

Catégorie:

Technologie de l'information, Télécommunications, Array

Salaire:

€500.00
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Nbre de vues:

6

Type d'emploi:

Temporaire

Publié:

06.12.2018


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Description de l'offre:

CSV Compliance Officer

Brussels region

12 months

We are looking for someone for the following role:

  • Improve computer system compliance within the customer
  • Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies.
  • Review user requirements, functional design specification, technical design specifications for clarity, Good documentation practices.
  • Review the accuracy and completeness of software validation deliverables created by the project functional process workstreams and the data migration, authorization and Infrastructure cross functional Project workstreams
  • Perform Validation and Qualification of GXP/Non GXP systems and infrastructure
  • Write and execute Computer System Validation (CSV) Protocols and Validation Summary Reports
  • Provide CSV expertise and risk analysis
  • Perform CSV GAP Analysis and develop the corresponding Remediation plans
  • Coordinate that software systems are implemented in conformance with CSV regulatory requirements and are in line with GAMP 5 standards
  • Supply technical guidance on global and local CSV policies and procedures

Profile:

  • Experience in Validation Engineering in FDA regulated Pharmaceutical or medical devices environment with concentration in Computer System Validation (CSV)
  • Experience with CSV in a SAP environment
  • Experience with the design of Validation documents like Validation plan, IQ/OQ/PQ Protocols, Test cases and Traceability Matrix, Summary reports.
  • Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and 820 and general principles of Software Validation Life Cycle.
  • Familiar with CSV compliant testing applications
  • Familiar with Infrastructure Validation is a plus
  • GxP advanced knowledge
  • GDPR basic Knowledge

If you are interested, please send in your CV to discuss further.




Informations sur la compagnie

DSR Global Ltd



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