Sinead O'Neill

• Maintained regulatory compliance through robust inspection processes aligned with GMP and internal quality standards.
• Performed comprehensive artwork inspections and managed artwork retain samples to ensure accuracy and consistency across packaging materials.
• Conducted detailed inspection of packaging materials and blister packs to ensure compliance and support timely batch release.
• Participated in daily cross-functional meetings, providing quality insights and supporting continuous improvement initiatives.
• Raised and managed non-conformances within the Quality Management System (QMS), including Supplier Corrective Action Requests (SCARs), Events, and QARs.
• Liaised with other departments, external vendors/suppliers to resolve quality issues and support testing activities.
• Prioritised batches for sampling, testing, review, and release to support production planning and supply chain continuity.
• Drafted, reviewed, and implemented Change Controls to support process improvements and product updates.
• Developed and implemented Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence.
• Reviewed inspection reports for accuracy, completeness, and compliance with internal and regulatory requirements.
• Investigated and processed customer complaints, identifying root causes and implementing corrective solutions.
• Collaborated with the warehouse team to ensure timely import, movement, and availability of batches for testing and release.
• Managed retain samples and associated documentation in line with regulatory and company requirements.
• Authored and updated Standard Operating Procedures (SOPs) and Work Instructions to ensure alignment with best practices and regulatory changes.
• Improved customer satisfaction through meticulous quality inspections and rapid issue resolution.
• Developed strategies to address product defects, driving improved product quality and operational performance.
• Championed process optimisation initiatives that increased efficiency, reduced waste, and strengthened compliance.
• Conducted root cause analyses on defective units, resolving issues promptly to support uninterrupted operations.
• Performed daily quality inspections and maintained accurate, audit‑ready documentation.
• Responded swiftly to reported quality issues, troubleshooting effectively to minimise operational downtime.

• Supported the packaging of solid-dose pharmaceutical products in a GMP‑regulated environment.
• Ensured strict adherence to GMP, EHS, and all health and safety procedures during daily operations.
• Performed hourly in-process checks, recording all data accurately and contemporaneously in accordance with ALCOA principles.
• Identified and resolved issues impacting product quality.
• Utilised SAP and IPL technologies for batch documentation, workflow management, and material tracking.
• Worked extensively with serialised orders, ensuring full compliance with traceability and regulatory requirements.
• Proactively supported continuous improvement initiatives to optimise processes, reduce downtime, and enhance the working environment.
• Reduced waste through efficient use of materials and resources.
• Liaised with Quality Assurance Specialists on an ongoing basis.

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