Senior Quality Assurance Associate Shift days RK5309 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The Sr. Associate in Quality Assurance will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components. Reporting to a QA Manager, they will serve as Quality point of contact for Incoming Inspection of Primary and packaging components. Key Responsibilities: Testing of primary and secondary components for use in the manufacture of aseptic products. Sampling of Excipients and Drug Substance under Grade C conditions. Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities Compiling, Review and approval of minor deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable Participates in customer complaint investigations with suppliers of components. Provide training and advice to staff in relation to testing of components and packaging. Actively participate in audits and their preparation. Review and approve c GMP records (e.g., WO, JP, GDMS, Deviation, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation Write, review and approve Standard Operating Procedures in accordance with company policies. Perform all activities in compliance with safety standards and SOPs Support continuous improvement and Operational Excellence initiatives Any other tasks/projects assigned as per managers request. Education and Experience: University degree in a Science-related discipline 4+ years experience working in the pharmaceutical or biotechnology industry Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations Experience working in aseptic operations, protein formulation, vial and syringe filling. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
