Ana Gabriella Alves

Specialist, Quality Assurance @Moderna

Laval, QC, CA

Proven expertise in ensuring compliance, managing quality events, and driving continuous improvement in regulated manufacturing environments. Key achievements and responsibilities include:Ensure adherence to cGMPs, SOPs, and manufacturing documentation to maintain regulatory compliance.Implement quality standards for Drug Establishment Licenses to enhance regulatory readiness.Manage quality events by leading root cause analyses, developing CAPAs, and ensuring timely resolution.Support commercial product supply by fostering a culture of Operational Excellence and continuous improvement.Conduct risk assessments and implement mitigations to minimize operational and compliance risks.Support product and process changes to ensure regulatory alignment.Deliver comprehensive training programs to enhance staff knowledge and ensure regulatory preparedness.Maintain audit and inspection readiness, acting as a key participant during audits.