Teva Pharmaceuticals USA, Inc.

Quality Engineer IT

US-CA-Irvine
Requisition #
17-19721
# Positions
1
Category
Quality - Quality Assurance

Overview

This role has the responsibility for being the independent Quality approver of IT documents.

 

The role involves managing complex IT problems and projects and includes the assessment of product and system impact for change controls, functional risk assessment of User Requirements, and ensuring that validation deliverables are met.

 

This role has also the responsibility of reviewing and approving change controls for critical utilities, manufacturing equipment, and control systems in use at the site. Duties include reviewing changes for their impact on products and the validated state of systems.

Responsibilities

Responsible to review and approve computer validation

documents such as validation plan, user requirements and

functional specifications, hardware design specifications, data

migration plans, test scripts, IQ/OQ/PQ, traceability matrix, configuration records and validation report.

 

Provide support to Manufacturing, Maintenance, Engineering, and other departments. Any major challenges and manufacturing issues are investigated from a quality perspective and documented.

 

Perform the review and approval of IT Change Controls

including testing, validation document and test scripts.

 

Provide support to site QA during incident/DR investigations.

 

Responsible for periodic reviews of the User lists to ensure                    

User roles are current and accurate.

 

Follows Teva Safety and data integrity procedures and policies

Qualifications

University degree in Science, Chemistry, Pharmacy or related discipline.

 

Three (3) + years in Quality Assurance, Quality Control, Technical Services and/or Production in the pharmaceutical industry.

 

 

cGMPs (Strong knowledge of CFR 21 Part 11) and Technical expertise working with Oracle (ERP), MS Windows XP/2000 MS Office, PowerPoint, Adobe Reader, Outlook Applications, LIMS, Harmony TrackWise.

 

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