Hi ,
Need : Trackwise- Business Support Admin Location : St. Louis, Missouri Duration : 12+ Months *Relevant Experience** : 8 + year* *Technical/Functional Skills* Knowledge and experience with the administration of TrackWise). - Familiarity with database management system - Strong understanding of the current pharmaceutical industry and applicable regulations. - Strong knowledge of 21 CFR Part and Annex 11 Regulations - Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks. - Experience in implementing and maintaining GXP computer systems in a validated state. *Roles & Responsibilities* This individual will perform the role of a Business Administrator in the Corporate Quality department for the TrackWise Application. - Performs daily business administrative tasks related to functional support (Level 2 Support) and general user account administration of the TrackWise - Drive the analysis, development, testing, and deployment of configuration, workflow, reporting and/or software updates to improve the overall accuracy, efficiency, and effectiveness of the system - Effectively identifies and resolves system issues and appropriately communicates gating items to management, Business Process Owner Leads and users - Conducts impact assessment of GXP computer systems related deviations and change controls. - Assist in end user training on TrackWise application as needed - Participates in the improvement and development of Quality Systems to ensure quality and adherence to cGMPs. - Works on problems of greater complexity in scope where analysis of situations or data requires in-depth evaluation of various factors, good judgment is required in resolving problems and making routine recommendations. - Exercises judgment within approved policies and procedures in selecting methods, techniques and evaluation criteria for obtaining results. -- Supports the development and management of quality metrics to optimize performance, productivity, effective resource planning, and management review. - Participates in cross-functional project teams. *Saurabh Sharma* SAP AND IT CONSULTING SERVICES 4606 FM 1960 Rd W, Suite 400 Houston, Texas-77069 T: 281 954 5503 Email: saur...@e-infionics.com <raj...@e-infionics.com> | saurabhsysmind...@gmail.com Web: www.e-infionics.com -- You received this message because you are subscribed to the Google Groups "Oracle Users" group. To unsubscribe from this group and stop receiving emails from it, send an email to oracle-users+unsubscr...@googlegroups.com. To post to this group, send email to oracle-users@googlegroups.com. Visit this group at https://groups.google.com/group/oracle-users. For more options, visit https://groups.google.com/d/optout.
