![]() ![]() *Developed SOPs for Change Control System, Exception Deviations, Periodic Review and Documentum *Requirement Traceability Matrix (RTM) (Design specs, Functional Specs) *Validation Deliverables: Validation Plan, Verification Strategy Document (VSD), Business Integration Model (BIM) flow charts, Exception/Deviations, Verification Completion Report, Validation Summary Reports and various site deliverables *Expert in creating, and reviewing validation documents in accordance with company policies and procedures. *Data migration process from legacy systems into Documentum (Wyeth and Hospira) *Expert in Document Management (Documentum, CARA) electronic document management system *Validated Electronic Document Management system (Documentum) v3 and v4, Learning Management System v3, Trackwise v3 and v5, GIDS, and MCAS 6.0 *Qualification of Infrastructure components according to company standards. Expert level of knowledge and understanding of SDLC and GRC validation methodologies. *Ability to work well independently and in a team environment. *Experience in communicating with Project Teams (Technical, Quality and Compliance): project timeline, creating deliverables, user trainings, testing, issues and problem solving *Experienced in guiding the project team in delivering validation deliverables *Highly proficient with all the phases of SDLC (System Development Life Cycle) process, and GRC (Governance, risk management and compliance ) validation methodologies ![]() *Experience in validating computer applications, Databases in accordance with 21 CFR Part 11 and GxP regulations. Experience in Information Technology as Document Control Specialist ![]()
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