Supports manufacturing operations on Quality issues.
Responsible for reviewing technical and quality documents including: batch records, product specification and test methods, validation reports, deviations and failure investigations.
Works to maintain and manage quality systems.
Supports or performs audits and inspections to assure compliance with regulations.
Review of Batch Manufacturing Records for bulk antigen and finished vaccines.
Release of intermediates.
Preparation of batch documentation prior to QP certification.
Perform GXP internal audits of facilities, systems and process and generate deficiency reports for the receiving departments.
Review and approval of process, system and analytical procedures.
Review and approval of process and analytical change controls.
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