Validation Consultant
Intellectt Inc
Our client is in need of an experienced and well-rounded CSV Consultant to join their team and support two ongoing projects, as well as additional projects, across multiple systems. Scope of Work SAS Studio Project – Our client began a lengthy project of installing SAS Studio, requiring them to internally manage AWS servers and migrate over. The consultant will own the validation portion of this project and need an understanding of how SAS Studio works and interacts with GxP data. Data Migration Project – The client is migrating data from their source system to their target system and creating a data migration plan/protocol. This will involve a lot of data clean up, data conversion, and field mapping. The consultant will need to utilize their knowledge of data migration tools they’ve used in the past to develop a plan/approach for the migration and also be responsible for getting appropriate documentation in place. Link Project and Argus Projects. All of the above systems are validated except for SAS Studio. SAS Studio is currently going through the revalidation process. The main role of this consultant will be owning the validation for these projects. Team Breakdown AD IT CSV, 2 CSV Consultants, and the Quality Team. Technology Environment SAS CTMS Medidata Veeva Quality Docs TraceLink SharePoint Microsoft Office – Excel, Word, Power Point, Outlook Submitting change requests for systems Meetings with stakeholders to ensure alignment Providing status updates Required Skills Previous experience as a CSV consultant at a pharmaceutical company, to include: Validating the Veeva Platform, such as: QMS, CTMS, RIM, or Quality Docs Developing UATs and writing test scripts Independently owning/authoring validation deliverables and working with cross‑functional teams Gathering requirements for URS Working with Veeva Change Control and understanding how the systems work, with the ability to create change controls and close them Working on data migration projects – knowledge of data migration tools, developing a plan/approach for a data migration, and getting appropriate documentation in place Desired Skills Working with SAS Studio and understanding how it works and interacts with GXP data #J-18808-Ljbffr Intellectt Inc
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