Job Description
This Quality Specialist will join a dynamic and hugely collaborative team as they continue to build out their Cork operations. This role will support across the day to day operations support, supplier engagement and on the validation of new processes. A bit more about the role: Review and approval of key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes. Participation in the internal audit program of areas for compliance with Product Quality Systems, policies, guidelines and procedures. Partners with Corporate QA, Manufacturing, QC, R&D and other cross functional partners to ensure the proper application of controls, risk management and the investigation/correction of failures/challenges. Collaborator with Engineering Dept on projects/ validation studies requiring QA review. Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. Conduct investigations, and approval of non-conformances, CAPAs and customer complaints. Escalate quality issues as appropriate Monitoring, trending and presenting metrics associated with site quality systems Active participant in the site CI programme. Key requirements: A degree-level qualification in Science/ Engineering discipline. Auditing experience (internal and/or external) At minimum 4 years previous experience working a similar role in a cGMP regulated food, healthcare or pharmaceutical industry. Experience owning and working through CAPAs, Deviations, Change Controls, Root cause analysis & validation. Six Sigma trained (preferred but not necessary) Knowledge of and implementation of CI tools If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on . Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative. BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES. Skills: Quality Assurance Quality Systems Investigations Supplier Quality Validation protocols