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Data Integrity Support Specialist

Job description

Data Integrity Support Specialist

Our client, a multinational pharmaceutical company is seeking an experienced Data Integrity Support Specialist for an 11-month contract in north Dublin.

Job responsibilities:

  • Responsible for the development and support of a DI Query / Issue Tracking system
  • Track issues and assign response criticality
  • Define initial metrics by which compliance to DI will be measured (in lime with project progress) and collation of metrics for presentation
  • Assist the business with Data Mapping including instruction on ALCOA Worksheet use and map generation
  • Support Data integrity activities for all systems- Laboratory, Manufacturing and IT
  • Assist in planning process for periodic audit trail review systems
  • Complete periodic DI audits across the site

Job requirements:

  • c in Science / Engineering discipline
  • Minimum of 5 years’ experience in a pharmaceutical environment
  • Minimum 2 years’ experience Quality experience
  • Knowledge of relevant GMP and DI standards
  • Deep understanding of current regulatory requirements and expectations
  • Validation of IT systems
  • General planning and Scheduling DI Experience of standalone, networked, hosted and SASS solutions
  • Understanding of system risk Register and Risk Management principles
  • Continuous improvement skills

If you would like to discuss this position, reach out to Louise Whitty on 021 2359140 / lwhitty@sigmar.ie

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