QA Specialist - NPIOur client in North Dublin are looking for a QA NPI Specialist on an initial 11 month contract. The successful candidate will have 3+ years GMP ezperience. The role ensures that the New Product Introduction objectives are effectively achieved, consistent to ensure compliance.Responsibilities: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 improvement initiatives and action plans in collaboration with cross-functional teams.Ensure the highest Quality, Compliance and Safety standards.Required:Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.Strong knowledge of qualification and implementation of Single Use technologies and raw materials and supplier qualifications for use in a GMP environment.Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.Proven track record in delivering excellence.Competency in the use of SAP, KNEAT, eVal and Veeva systems including change control is an advantage.Familiarity and participation in risk assessment processesBerkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to -