Data Validation Specialist

19 hours ago

Waterford, Waterford, Ireland beBeeValidation Full time €40,000 - €60,000
Job Title: Data Validation Specialist

A data validation specialist is required for a biopharmaceutical company in Waterford. The incumbent will ensure the ongoing validation compliance of computerised equipment and systems onsite.

  • Integrally involved in the validation of all new computerised equipment, and control systems onsite.
  • Generates validation documentation (protocols/reports) and helps with the execution of protocols for computerised equipment and systems.
  • Participates in the change control process advising on CSV issues, as appropriate.
  • Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
Required Skills & Qualifications:
  • degree in science or engineering
  • 3-5 years' experience working in a healthcare manufacturing environment
  • project management experience
  • capable of troubleshooting validation issues associated with projects, process development etc.
Key Responsibilities:
  • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
  • Maintain validation documentation through the approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
  • Generate/review/approve execution of the validation/revalidation plans.

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