The QC Senior Expert is responsible for reviewing and approving electronic analytical data, analytical batch records, and analytical reports to ensure compliance with cGMP, Data Integrity Principles, and regulatory requirements supporting the final QC batch release. The role involves audit trail review, analytical record verification, and metadata assessment, ensuring data accuracy, completeness, and integrity. Additionally, the QC Senior Expert acts as the Data Integrity Champion within the QC laboratory, supporting training, governance and compliance enhancement activities.

Key Responsibilities

• Review and approve electronically generated analytical data, batch records, test results, calculations, and analytical reports for accuracy, completeness, and compliance with specifications.
• Confirm that all batches under QC release meet approved specifications and have no pending deviations, out-of-specification (OOS) or out-of-time (OOT) findings.

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