• Identify and address quality issues from IQC, In-Process QC, Final QA, and Technical Support feedback.
• Plan and execute technical audits for critical vendors.
• Conduct root cause investigations and develop CAPA for internal and external issues.
• Perform FAIR, process validation (IQOQPQ), and follow up on CAPA implementation.
• Monitor and analyze quality metrics and vendor performance, formulating CAPA as needed.
• Conduct risk assessments and implement mitigation strategies for continuous improvement.

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