Review lot release data, identify testing discrepancies and participate in laboratory investigations.
Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
...
Develop and execute validation strategies to ensure systems remain compliant throughout their lifecycle, from implementation through ongoing operation and maintenance.
Prepare, review, and approve validation documentation including User Requirement Specifications (URS), Functional Specifications, Risk Assessments, Validation Plans, Traceability Matrices, IQ/OQ/PQ protocols, validation reports, and related lifecycle documents.
Review and approve CSV validation plans, protocols, and final summary reports to ensure they meet regulatory and internal Quality Management System (QMS) standards.
...
Provide deep technical oversight of wafer fabrication processes, including lithography, etch, deposition, CMP, implant, diffusion, and BEOL metallization.
Assess supplier process capability, SPC control, equipment stability, and defect management systems to ensure robust, scalable manufacturing.
Review and approve process documentation, control plans, PFMEAs, and manufacturing specifications.
...