Senior Quality Assurance Data Integrity Specialist

3 days ago


Limerick, Limerick, Ireland beBeeDataIntegrity Full time €80,000 - €120,000
Job Description:

Lead a team to ensure site data integrity and quality governance for electronic and computerized systems, such as MES, DeltaV, LIMS, ELN, SAP.

  • Implement data integrity and computer system validation processes, manage validation lifecycle, change control, deviations, and CAPAs.
  • Support regulatory inspections, maintain inspection readiness, and drive continuous improvement to contribute to global quality strategies.
  • Train and mentor staff in data integrity and CSV best practices.
Requirements:
  • Bachelor's or higher in Science, Engineering, Computer Science, or related field.
  • 10+ years of experience in quality/compliance within biopharma or biotech environments.
  • Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations.
  • Proficiency with lab and manufacturing systems, and validation tools.
  • Excellent leadership, communication, and cross-functional collaboration skills.

The ideal candidate will have a strong background in quality assurance, data integrity, and computer system validation.


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