Experience

UPS Healthcare

• United States
• Transportation, Logistics, Supply Chain and Storage
• 400 - 500 Employee

• Senior Software Quality Engineer

  • Feb 2022 - Present

• QA Validation Supervisor

  • Feb 2015 - Feb 2022

  Provide guidance on computer system validation (Global Systems)Review / approve changes related to cGMP systemsPerform Qualifications of peripherals and devices related to healthcare systemsDevelopment and creation of validation documents such as Validation Master Plan, User Requirements, Functional Requirememts, Design Specifications, Installation Qualifications, Operational Qualifications, Performance Qualifications, Validation Summary ReportsDevelopment and creation of Standard Operating Procedures and Work Instructions and training associated to themPerform due dillengence on systems to be used in healthcare environmentManage system validation projects and establish timelines.Ensure 21cfr11 and Annex 11 (PIC/s) compliance is being adhered toPerform audits of internal systemsManaging of Change Management processesManagement and coordination of validation project activites from beginning to endInstallation Qualification of Windows, Linux and AIX system platforms. Both Physical and virtual.Validations include SAP (ECC, BI, PI), Manhattan Associates (WMOS) and custom proprietary systems Show less

• QA Validation Specialist

  • Jun 2011 - Jan 2015

  Reviewing test cases/scripts against requirements.Developed and maintained training matrix/systemApproved and Assessed change controls