Senior Quality Assurance Specialist

Senior Quality Assurance Specialist / Manager (9-month Contract) Location: Dublin Contract: Temporary, 9 monthsA global biopharma organisation is seeking an experienced Senior Quality Assurance Specialist/Manager to support a busy period of new product introduction and technology transfer. This role requires strong batch release expertise and proven capability working within a GMP environment.Key ResponsibilitiesSupport the Qualified Person with batch certification activities.Prepare and review batch documentation packages in line with SOPs.Work closely with Supply Chain and Quality teams to ensure timely product disposition.Update SOPs, forms and training materials as needed.Contribute to NPI and tech transfer projects.Provide training and guidance to new team members.Support inspection readiness for corporate and regulatory audits.Participate in QMS activities including change control, self-inspections, quality agreements, complaints and product quality reviews.Identify and implement opportunities for process improvement.Ensure all work is completed in accordance with GMP, regulatory expectations and internal quality standards.Experience & QualificationsDegree in science, engineering or a related field.5-7 years experience in pharmaceutical or biopharma.Strong batch release and GMP documentation experience.Familiarity with electronic quality systems (e.g. DCA, Trackwise, Infinity, SAP).Strong MS Excel and PowerPoint skills.Excellent attention to detail, organisation and the ability to manage shifting priorities.The Next Step for you: Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website.