Provide quality oversight to ensure manufacturing activities comply with internal quality systems, applicable regulatory requirements, and customer expectations.
Support process and equipment validation activities, including review of validation protocols, reports, controls, and data integrity.
Lead or support investigation of quality issues using structured root cause analysis (RCA) methodologies and drive effective corrective and preventive actions (CAPA).
Prepare, review, and approve quality documentation such as control plans, inspection procedures, validation documents, and related records.
Collaborate with manufacturing teams to support continuous improvement initiatives while ensuring product quality and compliance are maintained.
Support supplier and component quality activities, including evaluation of supplier performance and quality-related issues, where applicable.
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