Perform validation including: IT systems, (Backup, IT infrastructure), Quality systems: EDMS, QMS, LMS, QC systems: CDS, LIMS, Instrumentation, Manufacturing systems, ERP, etc. Review and User Requirement Specification (URS) and/or Requirement Specification documents for equipment/systems and processes, Generate and execute Installation, Operational and Performance Qualification (IQ, OQ, PQ/UAT) protocols and final reports that comply with corporate and regulatory requirements. Coordinate and oversee validation protocol execution..
Aug 14, 2021