Julie Walsh

Irvine, CA 92618Cell: 949-933-5633 Home: 949-679-9730

julie.walsh262@gmail.comwww.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 FDA 21 CFR Part 11 Compliance SOX Compliance Data Flow and Process Mapping

Validation Documentation Test Script Writing, Execution and

Documentation Systems Administration

PROFESSIONAL EXPERIENCE

TEVA PARENTERAL MEDICINES, INC. (TEVA USA), Irvine, CA 1995 – 2009Teva 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.

Julie Walsh Page 2949-933-5633

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