Gisele Fahmi

Selbstständig, GIT (Global IT) Regulatory Affairs Project Manager, Baxter Healthcare

Chicago, Vereinigte Staaten

Fähigkeiten und Kenntnisse

Project/Program Management
Validation
Quality and Compliance
Engineering
IT and Manufacturing-Pharma and Biotech
Rockwell Automation
risk based validation
strategic operations

Werdegang

Berufserfahrung von Gisele Fahmi

  • Bis heute 13 Jahre und 1 Monat, seit Juni 2011

    GIT (Global IT) Regulatory Affairs Project Manager

    Baxter Healthcare

    Lead team of 12-15 team members (core and extended team) to ensure the quality and delivery of a R&D document management system on schedule and within budget using both internal/external resources including FirstDoc upgrade, eArchive solution and TRS Viewer (Total Regulatory Solution- important addition to the Total Regulatory Solutions portfolio enhancing regulatory submissions operations) for FirstDoc, and Documentum and Core Dossier Decommissioning projects. • Manage/Lead entire project including techn

  • 1 Jahr und 1 Monat, Sep. 2010 - Sep. 2011

    Senior Business Technology Quality and Compliance Engineer

    Pfizer Inc.

    Senior Business Technology Quality and Compliance Engineer for Business Technology - Finance and Business Operations Provide ELC coverage and assist with BT Compliance coverage for the PACE (Pfizer Achieving Commercial Excellence) program. PACE is the third largest Integration program at Pfizer of financial (SOX) systems between legacy Wyeth with legacy Pfizer. • Role includes working with Pfizer colleagues and consultants to man

  • 4 Jahre und 11 Monate, Aug. 2005 - Juni 2010

    Regulatory Information Systems Senior Quality Engineer and then Project Manager

    Amgen

    Project Manager/Change Owner/Release Owner To increase efficiency, compliance, and security around EBP (External Business Partners) provisioning and management leveraging both Identity and Role Management tools to facilitate access to internal applications for External Business Partners. • Utilized change and configuration management Tivoli IBM tools (IS Solutions Delivery) for IAM (Identity and Access Management) program • Interacted directly with IAM Program Manager and managed multiple workstreams

Ausbildung von Gisele Fahmi

  • 1998 - 2000

    Biomedical Engineering

    Univeristy of Montreal

  • 1995 - 1998

    Chemical Engineering

    McGill University

Sprachen

  • Englisch

    Muttersprache

  • Französisch

    Muttersprache

  • Arabisch

    Muttersprache

  • Spanisch

    Gut

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