Validation Consultant
Our client is in need of an experienced and well-rounded CSV Consultant to join their teamand support 2 ongoing projects, as well as additional projects, across multiple systems.o SAS Studio Project – Our client began a lengthy project of installing SAS Studio,requiring them to internally manage AWS servers and migrate over. The consultantwill own the validation portion of this project and need an understanding of how SASStudio works and interacts with GxP data.o Data Migration Project – The client is migrating data from their source system totheir target system and creating a data migration plan/protocol. This will involve a lotof data clean up, data conversion, and field mapping. The consultant will need toutilize their knowledge of data migration tools they’ve used in the past to develop aplan/approach for the migration and also be responsible for getting appropriatedocumentation in place.o Additional Projects: ETMF Update, CTMS Updates, Veeva QMS/QDS Projects, TraceLink Project, & Argus Projects.* All of the above systems are validated except for SAS Studio. SAS Studio is currently goingthrough the revalidation process. The main role of this consultant will be owning thevalidation for these projects.* Team Breakdown: AD IT CSV, 2 CSV Consultants, and the Quality Team.Technology environment the consultant will be working in:* SAS* CTMS Medidata* Veeva Quality Docs* TraceLink* SharePoint* Microsoft Office – Excel, Word, Power Point, OutlookConsultants day-to-day responsibilities:* Submitting change requests for systems* Meetings with stakeholders to ensure alignment* Providing status updatesRequired Skills:* Previous experience as a CSV consultant at a pharmaceutical company, to include:o Validating the Veeva Platform, such as: QMS, CTMS, RIM, or Quality Docso Developing UATs and writing test scriptso Independently owning/authoring validation deliverables and working with crossfunctional teamso Gathering requirements for URSo Working with Veeva Change Control and understanding how the systems work, withthe ability to create change controls and close themo Working on data migration projects - knowledge of data migration tools, developing aplan/approach for a data migration, and getting appropriate documentation in placeDesired Skills:* Working with SAS Studio and understanding how it works and interacts with GXP data