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Computerized System & Data Integrity Expert (Part-Time Contract)

July 2, 2025

Location: On-site (Budapest)
Duration: 6+ months
Commitment: Minimum 3 days per week
Start Date: ASAP
Language: Fluency in English required

We are seeking a highly experienced Computerized System & Data Integrity Expert to support site-level compliance efforts in line with GMP and global data integrity regulations (21 CFR Part 11, Annex 11). This is a key contract role focused on risk assessment, validation leadership, and data governance strategy for complex computerized systems.

Key Responsibilities:

  • Conduct Data Integrity Assessments and gap analyses on systems including SCADA, LIMS, PLC, and automated lab/manufacturing equipment
  • Perform System Criticality Assessments and support Computerized System Validation (CSV) activities
  • Develop and maintain site-level Data Integrity Master Plans, disaster recovery procedures, and documentation
  • Author/review/approve key CSV documents (URS, IQ, OQ, PQ, UAT)
  • Provide training and guidance on data integrity standards across departments
  • Participate in audits, incident investigations, and resolution of data-related deviations
  • Collaborate cross-functionally with Quality, IT, Engineering, and Manufacturing
  • Stay current with global data integrity regulations and best practices

Qualifications:

  • Technical/scientific degree or equivalent work experience
  • 5+ years of experience in computerized systems validation, data integrity, and GMP environments
  • Strong working knowledge of 21 CFR Part 11, Annex 11, and GAMP5
  • Demonstrated experience managing multi-system data governance frameworks
  • Excellent interpersonal and documentation skills

Experience
5+ Years
Work Level
Mid-Level
Employment Type
Contract, On-Site, Part Time
Jordan Griffiths
View profile
Industry
AL Solutions
Phone
+44 (0) 203 778 0909 +44 (0) 203 778 **** Show

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