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Details of the offer

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A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products.


The role Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.Develop and maintain quality assurance procedures, policies, and systemsConduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulationsInvestigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product qualityMaintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products.


The role Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.Develop and maintain quality assurance procedures, policies, and systemsConduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulationsInvestigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product qualityMaintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports The Person BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related disciplineMinimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environmentStrong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirementsExperience with quality management systems (e.g., TrackWise, MES) is a plus
For further details please contact;Paula O'Reillyon 087 7094141 or send CV in confidence to ******






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