Validation Specialist

6 ore fa

Italia, Italia ProductLife Group Tempo pieno

Specific activities and responsibilities:

  • Plan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements.
  • Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports.
  • Support clients in ensuring Data Integrity compliance in accordance