CSV Engineer

Posted 03 September 2021
SalaryExcellent Package
Job type Contract
DisciplineLife Sciences & Engineering Technologies
ContactRachel Duggan

Job description

A global leader in pharmaceuticals has established their central site in Leinster and are currently searching for an experienced computer systems validation specialist for their rapidly expanding QA department.

This company is a current industry leader, operating a large scale start-up environment with more than 100 clinical trials taking place within their European HQ site based here in Leisnter. This QA team is operated with high-calibre, state-of-the-art equipment and systems.

Main responsibilities:
* Quality review and approval of Computer System Validation (CSV) and IT compliance documentation and associated data for conformance to regulations
* Review and approve computerised system validation documentation, including; URS, FDS, Test Protocols/Reports, SOPs etc.
* Participate in software, equipment and instrument qualification where necessary.

The ideal candidate:
* Strong experience in a Quality Engineering/Quality Assurance role
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices
* Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)

- Highly competitive rate, depending on experience.

For more information, contact Rachel at or call 0894937334 to have a call in strict confidence.