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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.