Job ID: 11760

CSV / Data Integrity Consultant (m/w/d)

Stellenart.

Project Consulting

Ihre Aufgaben.

Activities

  • Commit to, support and implement the Data Integrity (DI) Program onsite
  • Apply the Data Integrity regulations as described a.o. in Eudralex vol 4., FDA 21 CFR part 11, ISPE guidelines, WHO annex 5, as well regulations as described in the internal guidelines, SOPs, work instructions
  • Train and coach staff, if required, in the defined departments according to internal SOPs, works instructions and toolkit
  • Implement DI Activities in the context of the internal Data Integrity Implementation Program (create process flows, data flow diagrams, IT systems gap assessments, risk assessments as well as remediation activities for defined processes and systems as per internal tool kit)
  • Remediation Activities in the context of the Data Integrity Implementation Program
  • Document these activities/results as per Good Documentation Practices and internal SOPs and guidelines

Achievements

  • Comprehensive Data Flow Diagrams (documented), System/Paper Assessments (documented), Risk Assessments (documented)
  • Remediation support for various departments, systems and (investment) projects including the agile DI Team
  • Continuous improvement of the Data Integrity Maturity Level of the specific department through adherence of defined milestones

Ihr Anforderungsprofil.

  • Average of 3 to 6 years of hands-on CSV / DI experience
  • Proven experience (process/equipment) with data integrity in a GMP regulated environment
  • Good Documentation Practice in Pharma and Biotech domains
  • Solid experience with GxP regulations both FDA as well as EU

Vorteile.

Keine Angaben

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