Serena Cuddy

Manage the PLM system including setup/configuration, user permissions, product data, BOMs and lifecycle workflows. Generate management reports, liaise with vendors for licences/training/configuration, and provide user support and troubleshooting to maintain system performance.

Championed operation and improvement of the eQMS, established and maintained SOPs and training for personnel, and coordinated external audits and supplier quality activities. Improved documentation repository strategy and supported business-wide controlled documentation generation.

Reviewed, wrote and updated SOPs, batch records and production specifications to ensure compliance with company policies and GMP standards. Managed CAPAs, performed internal/external audits, and compiled quality metrics to monitor system performance.

Provided QA oversight for batch documentation and change control, conducted internal audits and supported preparation for 3rd party and regulatory inspections. Authored and reviewed QARs/LIRs/VIRs and CAPAs, drove root-cause analysis and continuous improvement initiatives.

Implemented document control and Zero Defects initiatives, authored SOPs, forms and training content, and managed controlled document distribution for operations. Provided backroom audit support, compliance metrics reporting and assisted closure of quality investigations.

Created standard documentation templates and operating procedures for large-scale manufacturing, collaborating with SMEs to ensure technical accuracy and consistency. Prioritised and managed documentation to reduce backlog and meet global quality standards.

Assisted preparation of regulatory documentation in line with Eudralex Volume 4 and 21 CFR, supported variations and responses to health authorities, and aided inspection readiness and site master file compilation. Responded to regulatory requests from affiliates and supported on-site GMP inspections.

Assisted internal and external audits, managed documentation and complaint investigations, performed sample archiving and supported quality metric monitoring and calibration activities during a college placement. Edited and reviewed controlled documents in accordance with Eudralex/21 CFR.

Completed a Bachelor of Science (Honours) in Pharmaceutical and Biomedical Chemistry at Maynooth University from 2013 to 2017.

Completed the Leaving Certificate at Heywood Community School in Ballinakill in 2013.

Completed Internal Auditor Certification for ISO 9001:2015.