• Participate as functional expert in the cross functional team that manages production right first time.
• Review and approve batch, cleaning and testing documentation.
• Ensure that all Laboratory Out of Specification (OOS) and Process Deviations are documented, assessed and associated CAPA identified.
• Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
• Provide guidance on quality requirements to maintain validation status, including participation in Process / Product Risk Assessments.
• Provide feedback on re-occurring issues ensuring continuous improvement to systems / processes.
• Ensure change controls raised are documented, assessed and completed.
• Prepare Annual Process and System Reviews.
• Act as lead /team auditor to support the internal GMP walkdown and scheduled audits.
• Participate in the generation and communication of quality metrics.
• Creation, review and approval of quality procedures as required.
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