A global biopharmaceutical company in Dublin have an exciting opportunity for a NPI Senior Analyst to join their team. The ideal candidate will provide expert technical and analytical support to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology. The individual should be qualified to graduate level/or equivalent in a scientific discipline, with experience of working in a Good Manufacturing Practice laboratory environment. Will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Global Laboratory Practice. Must have An understanding of the Quality Control function, and its role and importance to the business. Principal Responsibilities: Perform all lab functions in compliance with cGMP Follow written protocols for Transfer and Validation activities Troubleshoot new methods as required Ensure training is current for all job functions performed Provdie QC SME and day to day technical guidance for NPI activities Support the NPI management team as required Lead and complete execution of investigations/CAPAs in a timely manner Training lead in specific assays overseeing the execution of all training activities for all new personnel Drive continuous improvement initiatives within the QC department Qualifications and key competencies: In depth knowledge of current regulatory requirements for Chemistry or Biochemistry methods in support of cGMP operations supporting clinical and commercial manufacturing Good technical knowledge in the area of Biochemistry or Chemistry. Good experience in investigation methodology and method troubleshootingg Ability to follow written procedures with close attention to detail Good report writing and technical writing skills. Ability to function with minimal supervision for routine job duties Education: BSc in Chemistry or a biological science, 4-7 years experience, or equivalent combination of education and experience. Skills: method transfer validation Laboratory Troubleshooting NPI
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