This document provides a summary of Julie Walsh's professional experience as a highly skilled Business Systems Analyst with over 20 years of experience implementing systems in sterile pharmaceutical environments. Her expertise includes supporting quality assurance, change control, validation documentation and FDA compliance. She has extensive experience managing projects, implementing ERP systems like Oracle, and developing databases to support business processes.

1. JULIE WALSH
Irvine, CA 92618 julie.walsh262@gmail.com
Cell: 949-933-5633 Home: 949-679-9730 www.linkedin.com/in/juliewalsh8
SUMMARY
Highly adept Business Systems Analyst with extensive experience in implementing sterile
pharmaceutical, technical and business systems. Key strengths include brainstorming and
problem-solving, training, and collaborating across multi-functional teams at all levels.
Organized, detail oriented and proficient ERP functional professional. Expertise includes
supporting data and projects in cGMP Pharmaceutical Quality Assurance, Change Control and
documentation including:
• GxPharma Compliance • Validation Documentation
• FDA 21 CFR Part 11 Compliance • Test Script Writing, Execution and
• SOX Compliance Documentation
• Data Flow and Process Mapping • Systems Administration
PROFESSIONAL EXPERIENCE
TEVA PARENTERAL MEDICINES, INC. (TEVA USA), Irvine, CA 1995 – 2009
Teva USA is a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., a global
company specializing in the development and production of generic and branded
pharmaceuticals, as well as active pharmaceutical ingredients.
Project Manager, New Products (2009)
Managed new product launches for the US Sterile Injectable Market. Managed a dynamic Oracle
Demand Planning System for both pipeline and inline products.
• Chaired weekly launch team meetings, providing project management support for more
then 50 products, identifying and reporting potential risks impacting launch, facilitated
contingency plans and corrective actions when required.
• Managed Oracle Demand Planning System with over 350 pipeline and inline products,
ensuring accuracy and timely reporting to manufacturing site planners.
• Rebuilt product master data to use in Oracle Demand Planning System for all pipeline
and inline products that prevented inaccurate data within a dynamic Global ERP system
serving 30 sites.
• Implemented and administered a functional dynamic Global Lotus Notes Project
Management Database, resulting in shared communications by all sites and
accountability to business units to complete tasks on time.
• Facilitated the data management and global reporting of over 150 sterile products in
development, ensuring accurate and timely communication of project updates.
Systems Analyst (2005 – 2009)
Sr. Documentation Control Systems Coordinator (2003 – 2005)
Documentation Control Systems Coordinator (1997 – 2003)
Developed, implemented and administered electronic systems to support all QA/QC business
processes. Oversaw all IT Project Integrations as a part of a global initiative to convert paper
systems to electronic, in accordance with 21 CFR Part 11.
• Implemented and facilitated the Item Master, Product Development and Quality modules
of an Oracle ERP System. This large scale project led to increased efficiency in
manufacturing and inventory management, as well as decreasing product backorders.

2. Julie Walsh Page 2
949-933-5633
Systems Analyst /Sr. Documentation Control Systems Coordinator (continued)
• QA Documentation Control lead for the implementation of Documentum, TrackWise
• As MS Access database administrator, developed and maintained databases, supporting
QA, Microbiology, Manufacturing and Compliance processes that improved reporting and
tracking of product specific statistics.
• Maintained all master data and records including SOPs, Log Books, and Tutor
documentation associated with regulatory audit requirements, which ensured required
deadlines were met.
• Provided training to over 150 members of management and personnel to support system
implementations company wide, resulting in enhanced trainee’s utilization of the system.
• Served as an active and vital member of the FDA 21 CFR Part 11 compliance team
which influenced the evaluations of new systems and processes.
• Implemented and managed an Intranet based Webpage, providing dynamic database
status updates, reporting of change control processes, and Intranet access to cGMP
business process forms.
Administrative Assistant – Engineering (1995 – 1997)
Provided administrative support to the Vice President of Engineering, Validation, and
Maintenance and VP’s staff. Converted, upgraded, and controlled MS Access electronic
Engineering Request Systems to support all engineering business processes and Capital
Expenditure Request tracking, reporting and charge back allocation to business units.
• Improved the Engineering Request System and Project Time Management systems by
converting from MS Excel in MS Access, providing reporting that facilitated decision-
making and expedited project timelines.
• Administered and maintained 8 commercial property lease contracts, ensuring
contractual agreements were upheld.
• Managed company-wide pager service to guarantee communication among employees.
• Supported and coordinated team of 10 engineers during the construction of a new state-
of-the art oncology manufacturing facility.
SYSTEM IMPLEMENTATION EXPERIENCE
Oracle ERP: Item Master, Inventory Management, Demand Planning, Manufacturing, and
Quality modules, supporting Finance, Planning and Purchasing
Documentum Electronic Document Management
:
TrackWise: CAPA and Deviation Management
MS Access: Microbiology, Compliance, Quality Assurance, and Manufacturing
TECHNICAL SKILLS
Proficient in MS Office, Test Director, MS Project, MS Visio, Lotus Notes
Experienced with dBase III, Paradox, SQL, Visual Basic and HTML