Jersey City, NJ, USA
12 days ago
CSV Lead
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Job Duties: 

Participate on cross-functional project teams including development & deployment teams as well as Manufacturing, Engineering, Quality, and other groups. Compile and analyze validation data and make recommendations for changes and/or improvements. Maintain all documentation pertaining to computer systems validation.Support activities that include but are not limited to document review and approval Including assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols (IO/OQ/PQ), traceability matrix, error reports/defect report forms and summary reports.Provide guidance on all validation activities to validate computer software and systems.Conduct timely validation of security patches in the system. Ensure data integrity in the process and System Serve as key Commissioning, Qualification and Validation (CQV) point of contact for global development and deployment program. Co-ordinate and execute training of required personnel on the computer and automation systems validation procedures and methodology.Keep assigned systems and processes developed for computer and automation systems validation up to date and compliant.Optimization of CQV support process, including developing standards and KPI reports. Ensure standardization and efficiencies across multiple projects.Contribute directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols (IO/OP/PQ), reports and data tables generated by peers and contract personnel.

Education: The minimum qualification required for the performance of the above specialty occupation duties is a bachelor's degree or equivalent in Computer Science or equivalent in a related field or a foreign equivalent is required closely related field with relevant experience. 

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