Dania Lyew

Experience

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  Empresa Panameña de Alimentos

  Feb 2019 - Aug 2020

  Food Microbiologist

  • Expertise in operating and maintaining analytical and microbiological laboratory equipment (HPLC, GC, FTIR, UV-Vis, mass spectrometry, autoclaves, incubators, etc.).• Conducted comprehensive microbiological analyses to detect and quantify pathogens in raw materials and finished products, ensuring each batch met stringent safety and quality standards for product safety and compliance.• Effectively communicated and collaborated with cross-functional teams, including factory leads, R&D, and other engineers, to design and implement HACCP for the company to obtain ISO 22000:2018 certification. • Conducted internal audits and prepared documentation for external inspections, ensuring alignment with industry regulations.• Supervised the quality management system (QMS) in a laboratory setting, ensuring adherence to ISO 17025 standards and implementing process improvements to enhance efficiency.• Trained laboratory staff on quality standards, procedures, and the proper use of laboratory equipment.• Analyzed complex data sets to generate detailed quality reports, supporting decision-making and continuous improvement initiatives. Show less

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  AstraZeneca

  Nov 2022 - Sept 2024

  Quality Assurance Specialist

  • Created reports and dashboards to manage 500+ quality events across the Andean Cluster, Panama, Mexico and Southcone for efficient tracking, analysis and alignment with GDP and GMP standards. • Enhanced engagement and leadership with key departmental stakeholders to gather essential feedback, integrating their insights into the investigative processes for resolving complaints and deviations effectively.• Developed customized risk assessments and designed strategic action plans, overseeing their implementation until the successful closure of change controls.• Conducted impact assessments to manage risks associated with local changes, ensuring the protection of critical attributes potentially affected by these changes.• Provided training to lab teams and supported lab technician based on ISO 17025.• Led effectiveness checks with project stakeholders to ensure end-to-end fulfilment of objectives while adhering to stringent quality protocols.• Conducted internal audits and external inspections. • Generated, tracked, and followed up on deviations and Corrective and Preventive Actions (CAPAs) to ensure processes improvement and enhance efficiency and quality. • Built strong relationships with local and international stakeholders as the reporting person for quality related matters. • Participated in GEMBA walks, preparing a comprehensive final report detailing the management of AZ products in Panama by 3PL J Cain, including improvement recommendations.• Maintained a comprehensive quality documentation and reported accordingly. • Managed the investigative process to obtain batch disposition approvals, ensuring timely product release to meet customer demands. Show less

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  DHL Supply Chain

  Oct 2024 - now

  Quality Assurance Specialist - Healthcare

  • Represented QA as a delegate in Quarterly Business Review (QBR) and Monthly Business Review (MBR) meetings with clients. • Prepared and analyzed Quality KPI data for QBR and MBR sessions. • Proposed and implemented improvement initiatives, achieving increased efficiency and cost savings. • Monitored and enhanced quality standards, ensuring compliance with GMP and GDP regulations. • Collaborated regularly with the Qualified Person (QP) and Responsible Person (RP) to identify and execute compliance and process improvements. • Contributed to improving QA's role in Performance Dialogs to enhance team and client collaboration. • Ensured optimal client service through effective use of the Quality Management System (QMS). • Coordinated and supported client audits, serving as a liaison and ensuring audit readiness. • Acted as a Subject Matter Expert (SME) for QA tasks, including change control and deviation management. • Drafted, reviewed, and obtained authorization for Technical Quality Agreements (TQAs). • Reviewed processes and documentation to ensure compliance with regulations and client agreements. • Managed changes, deviations, root cause analyses, and Corrective and Preventive Actions (CAPAs), ensuring timely approvals and implementation. • Conducted trend analyses on quality KPIs, identifying areas for improvement. • Executed and reported on internal audits, proposing corrective actions and ensuring regulatory compliance. • Developed CAPA plans post-client audits in coordination with stakeholders. • Participated in risk assessments for both projects and change implementations. • Continuously improved client and internal QA processes, providing feedback for enhanced team efficiency. • Trained and advised QA team members and cross functional departments on quality standards and practices. • Consistently ensured client related Quality KPI targets were met or exceeded. Show less