Job Description
As the Sr. Specialist Quality Engineering (QE) you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Tarzana facility. This includes Quality Review and Approval for including Quality Risk Assessments, Technical Reports, Validation Planning, Change Controls, Validation Protocols, Reports, as well as leading the technical quality arm of the Quality department.
You will ensure that operations are compliant with the cGMP standards established by AstraZeneca and relevant regulatory agencies.
Responsibilities
You will provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the quality and manufacturing objectives in support of site goals.
Represent the QE department and/or the Quality Organization on assigned site governance and operational teams internally, and as an empowered functional representative externally to ens...
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