Roch Sylvestre

Healthcare Quality Assurance Associate Manager - I.T. System Auditor at UPS Healthcare
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Contact Information
us****@****om
(386) 825-5501
Location
CA
Languages
  • English Professional working proficiency
  • French Native or bilingual proficiency
Skills

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Credentials

  • Certified Quality Auditor (CQA)
    American Society for Quality (ASQ) - MENA
    Apr, 2019
    - Nov, 2024

Experience

  • UPS Healthcare
    • United States
    • Transportation, Logistics, Supply Chain and Storage
    • 400 - 500 Employee
    • Healthcare Quality Assurance Associate Manager - I.T. System Auditor
      • Sep 2014 - Present

      Responsible for auditing GxP systems with adherence to 21 CFR Part 11 as well as Annex 11. Oversee Quality Assurance aspects for conversion of clients from legacy proprietary Logistics Management System to SAP (Order Management System) and WMOS (Manhattan Associates Warehouse Management System) Coordination of Compliance knowledge training for Canada Controlled Drugs on internal proprietary UPS Regulatory Compliance System (RCS) as well as SAP and WMOS. Recommendation and implementation of process changes to support efficient conversion process. Continuous improvement of processes and tools for Conversion program Review, update and creation of Work Instructions and Forms required for client conversions Creation of Change Controls and Move protocols to facilitate the client conversions Review of configuration documents related to the client conversion activities Participate in the development of the client transitioning documents to determine the requirements needed for the conversion.

  • UPS Supply Chain Solutions
    • United States
    • Transportation, Logistics, Supply Chain and Storage
    • 700 & Above Employee
    • QA Validation Supervisor
      • Jun 2008 - Sep 2014

      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, establish timelines, budgets and resource needsEnsure 21cfr11 and Annex 11 (PIC/s) compliance is being adhered toPerform audits of internal systemsHost audits for external representativesDevelopment 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

    • Data Security Specialist
      • Jan 2006 - Jun 2008

      Responsible for setting up Network User Access and various Customs Brokerage Application access. Performing Internal audits of user system accessCreation of Standard Operating Procedures and Work instructions related to security access processesParticipate in audits related to SOX, HIPPA and cGMP compliancePerform training and publish communications to inform employees about security policies and proceduresMaintain records of user access for all cGMP regulated systemsProvide guidance related to the implementation of security into existing and new applicationsDevelop, review, implement and train individuals on security policies as it relates to Information Technology / Healthcare cGMP regulations and regulatory proceduresWork with all system administrators to minimize security vulnerabilitiesDevelop and maintain forms utilized to request access to systemsImplementation of a Biometric system for computer system and application access.

    • Bilingual IT Service Desk Analyst
      • Feb 2005 - Jan 2006

      • Provide UPS-SCS personnel and external clients with a single point of contact for all technology related issues via telephone and email. • Log and prioritize problem tickets and assign to proper support department for resolution, escalation and successful completion. • Conduct Post Mortems to be sent to management with details of root cause, client impact time, affected locations and preventative / corrective action to prevent reoccurrence. • Follow up with UPS-SCS personnel and external clients to ensure incidents have been addressed to their satisfaction. • Assume role of P1 Manager and Team Lead Manager on a weekly rotating basis to ensure priority issues are attended to in a timely manner.

Education

  • Toronto School of Business
    Associate's degree, Internet Programming & Network Administration
    1999 - 2001
  • Niagara College
    Associate's degree, Hospitality Administration/Management
    1990 - 1993

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