Data Integrity Consultant for Pharma (m/f/d) – Freelance – on hold

  • Position zu besetzen ab 15. Mai 2021
  • Permanent-ID OCR-FL-1302
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Activities:

  • Commit to, Support and Implement the Data Integrity Program,
  • Apply the Data Integrity regulations as described in Eudralex vol 4., FDA 21 CFR part 11, WHO annex 5 as well as the clients guidelines, SOPs, work instructions,
  • Execute Data Integrity Trainings and Coaching in the defined departments according to the clients products and tool kit,
  • Create Process Flows, Data Flow Diagrams and respective Risk Assessments, together with clients staff, according to clients tool kit for defined processes and flows,
  • Execute (IT) System Assessments and respective Risk Assessments, together with clients staff, according to clients tool kit for defined (computerized) systems,
  • Document the activities and results as per Good Documentation Practices and the clients guidelines,
  • Implement Remediation Activities in the context of the clients Data Integrity Implementation Program,
  • Report to the DI PPO (primary process owner) or delegate on a regular basis.

Achievements:

  • Comprehensive Data Flow Diagrams (documented)
  • System Assessments (documented)
  • Risk Assessments (documented)
  • Remediation support (reporting)

Experience:

  • Average of 3 to 10 years of hands-on GxP experience
  • Proven experience (process/equipment) with data integrity in a GxP environment
  • Good Documentation Practice in Pharma and Biotech domains,
  • Solid experience with GxP regulations both FDA as well as EU

 

Additional information:

Location: Greater Frankfurt / Remote

Project start: 15.05.2021

Duration: ca. 12 months

Availability: 3-5 days / week

Remote & on-site support: tbd.

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