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.
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
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.