QA Engineer

• Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
• Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements.
• Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts.
• Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
• Influence and oversee Maintenance/Calibration programs within the Foundry, including benchmarking with other Lilly sites.
• Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA).
• Escalate and/or initiate notification to management for departures of critical nature and assure issues are addressed appropriately.
• Ensure the Foundry is audit ready at all times and participate in internal/external inspections.

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