Global Computer Validation Specialist needs 2 – 3 years’ experience writing CSV test scripts, protocols and summary reports

Global Computer Validation Specialist requires:

• Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.


• 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.


• 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.


• experience including the validation of global data repositories (warehouse / data lake) with analytics and collaboration tools in a GxP environment; have a 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.


• clinical trial


• computer validation


• document management


• documentation.

• FDA


• GMP


• GXP


• IT INFRASTRUCTURE


• learning management


• PIC


• project manager


• risk assessments


• statistical analysis


• test plans


• test scripts

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