TrackWise Architect - 21 CFR Part 11 Strong and Life Science domain

Job Title: TrackWise Architect - 21 CFR Part 11 Strong and Life Science domainLocation: Boston, MA (Hybrid)Employment Type: Contract About Smart IT Frame:At Smart IT Frame, we connect top talent with leading organizations across the USA. With over a decade of staffing excellence, we specialize in IT, healthcare, and professional roles, empowering both clients and candidates to grow together.Role SummarySolution Architect responsible for designing and governing TrackWise QMS solutions including enhancements integrations and compliancedriven implementations for regulated life sciences environmentsKey ResponsibilitiesDesign endtoend TrackWise QMS architecture 7x 8x 9x DigitalLead solution design for CAPA Deviation Change Control Complaints Audit Training modulesDrive TrackWise configuration customization and performance optimizationDefine and govern integrations with SAP LIMS DMS PLM and reporting toolsEnsure compliance with GxP 21 CFR Part 11 Annex 11Support CSV activities URS FRS IQ OQ PQProvide technical leadership and solution walkthroughs for stakeholdersRequired SkillsStrong handson expertise in TrackWise QMSExperience in Pharma Life Sciences quality systemsGood knowledge of databases Oracle SQL Server and reportingProven experience in solution architecture and client engagementMandatory Skills: Trackwise