QA Specialist II

6 days ago


Cork, Ireland Harry Walsh Associates Ltd. Full time

QA specialist required for a 12 month contract with a leading pharmaceutical client. This specific role is required to perform QA review of manufacturing, QC and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. Oral solid dose experience is essential. Experience 4+ years of relevant experience in a GMP environment related field and a BS. Experience in oral solid dose pharmaceutical industry essential Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems) Demonstrates working knowledge of quality assurance systems, methods and procedures. Demonstrates audit and investigation skills, and report writing skills. Good verbal, written, and interpersonal communication skills. Proficiency in Microsoft Office applications.


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