Role Summary
Solution Architect responsible for designing and governing TrackWise QMS solutions including enhancements integrations and compliancedriven implementations for regulated life sciences environments
Key Responsibilities
Design endtoend TrackWise QMS architecture 7x 8x 9x Digital
Lead solution design for CAPA Deviation Change Control Complaints Audit Training modules
Drive TrackWise configuration customization and performance optimization
Define and govern integrations with SAP LIMS DMS PLM and reporting tools
Ensure compliance with GxP 21 CFR Part 11 Annex 11
Support CSV activities URS FRS IQ OQ PQ
Provide technical leadership and solution walkthroughs for stakeholders
Required Skills
Strong handson expertise in TrackWise QMS
Experience in Pharma Life Sciences quality systems
Good knowledge of databases Oracle SQL Server and reporting
Proven experience in solution architecture and client engagement
Skills
Mandatory Skills : Trackwise
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