Qualification & Validation

Tasks

  • Support in the management of qualification and validation of process equipment, facilities and utilities in GMP context
  • Preparing, executing protocols and/or reviewing protocols from vendors
  • Support in development and revision of all qualification documentation: URS, Validation Plan, FS, DQ, IQ, OQ and PQ
  • Manage vendors activities

Skills

  • Knowledge of FDA and Eudralex (Annex 15 and Annex 11)
  • Experience with Commissioning activities and Good Engineering Practices (GEP)
Details
Activated at 02/22/2019
Locations Lisbon | Portugal
Category Consultants
Contact Nathalie MADEIRA
Reference AD002132