RxCloud is a leading provider of quality engineering and regulatory compliance services focused on the life sciences sector, including pharmaceuticals, biotechnology, and medical devices. With over 1000 years of combined IT and domain expertise, RxCloud specializes in offering a range of services such as GxP audits, quality management consulting, and IT systems validation. They prioritize efficiency, compliance, and innovation, helping their clients navigate the complex regulatory landscape while maintaining high quality standards in their operations.
Validation β’ Testing β’ Automation β’ GxP β’ GMP
February 5
π² Oregon β Remote
β° Full Time
π‘ Mid-level
π Senior
π§ Business Analyst
π¦ H1B Visa Sponsor
RxCloud is a leading provider of quality engineering and regulatory compliance services focused on the life sciences sector, including pharmaceuticals, biotechnology, and medical devices. With over 1000 years of combined IT and domain expertise, RxCloud specializes in offering a range of services such as GxP audits, quality management consulting, and IT systems validation. They prioritize efficiency, compliance, and innovation, helping their clients navigate the complex regulatory landscape while maintaining high quality standards in their operations.
Validation β’ Testing β’ Automation β’ GxP β’ GMP
β’ Efficiently lead the conversation β’ Represent the IS Regulatory Affairs workstream β’ Provide project updates/statuses regularly β’ Ensure document/data imported/exported into/from the Veeva RIM system β’ Coordinate with the migration team to execute data migration/export β’ Create a project plan, manage and execute it β’ Work with the Onsite-Offshore team for delivery β’ Work with multiple vendors to execute the project
β’ Business Analyst with Regulatory Affairs Merger & Acquisition experience β’ Regulatory data migration experience β’ Efficiently lead the conversation β’ Gather requirements from Business β’ Understand the concerns β’ Identify the risk β’ Communicate it promptly β’ Working knowledge of Veeva Vault RIM is preferred β’ Authored and review Data Migration Plan β’ Experience with HP Application Lifecycle Management (ALM)
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