Senior Quality Assurance specialist NPI - Biotech DublinContract with a view to extension.Please send your cv today for more details.Rachel Review and approve change controls, corrective and preventive actions (CAPAs), deviations including investigation protocols, root cause analysis and final investigation reports.Review and approve batch recordsReview and approval of Equipment qualification including IOQ and PQ, process validation, development studies, hold time studies etc.Provide quality assurance support across functional and cross-functional forums.Oversee quality aspects of material and supplier management, including preparation of material qualification packages, supplier audit assessments, and maintenance of the supplier management system.Collaborate with stakeholders such as Quality Control (QC), Manufacturing Science & Technology (MS&T), Engineering, and Warehouse to develop, review, and maintain documentation and quality records throughout the product lifecycle (e.g., method validations, facility upgrades, qualification protocols, calibration records).Review and approve Good Manufacturing Practice (GMP) documentation and data to ensure accuracy, completeness, and compliance.Partner cross-functionally to support timely delivery of project milestones.Contribute to the identification, development, and execution of continuous improvementEducationBachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.5 to 8 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.