Ensure that site Computer System Inventory list is maintained and remains current. Author or reviewer of validation documentation, such as validation plans, requirements specifications, validation protocols, test plans, summary reports and related change controls, ensuring that the technology solutions being implemented are compliant with all intern procedures (local and corporate policies). Review computer system validation protocols to ensure compliance and adherence with corporate guidelines and procedures. Consider the business use, data integrity, security, access, and safety for all systems undergoing validation. Team member of quality to resolve and manage CAPAs. Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk and follow quality management practices. Basic Requirements Basic knowledge of Computer System Validation process. Basic knowledge of Change control and CAPA. Additional Preferences Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
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