$170K — $180K
Global Computer Validation Specialist needs strong validation experience including the validation of global data repositories (warehouse / data lake) with analytics and collaboration tools in a GxP environment
Global Computer Validation Specialist requires:
· good understanding of IT infrastructure terminology and concepts and a thorough understanding of electronic records and electronic signatures requirements (FDA, PIC/S, Annex 11). Must have excellent oral and written communication skills. Must be able to manage multiple validation projects at one time; work independently and work with global business and IT members with limited validation experience.
· Experience validating systems used to support clinical trials in a pharmaceutical environment (e.g. eTMF, CTMS, safety systems, clinical trial registration, statistical analysis, EDC) and GMP/QMS activities (e.g. labeling artwork management, serialization, document management, learning management) preferred.
Global Computer Validation Specialist duties:
· Hands on position responsible for validation of GAMP 5 Category 4 (configurable off the shelf) computer systems in a GxP environment.
· Authors all validation deliverables including risk assessments, validation plans, user requirements, test plans, test scripts, traceability matrix, test summary reports, and validation summary reports.
· Reviews executed test scripts. Provides input to the project manager for all validation activities and deliverables.
· Reviews vendor provided documentation for suitability.
· Participates in project team meetings with IT and Business.
· Requires participation in early morning and/or evening teleconferences with global project teams.
Valid through: 4/22/2021
$140K — $180K + $15K bonus
2 days ago