The role: PE Global is currently recruiting for a QA Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 12-month contract role.
Description This role is a QA Specialist II, the QA Department, under the QA General Operations team. 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. Responsibilities: Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements. Reviews routine manufacturing, QC and engineering documentation including batch manufacturing records. Assists in the completion of Manufacturing related customer complaint investigations. Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents. Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions. Review and approval of GMP Deviation investigations and CAPAs. Identifies problems and generates alternatives and recommendations. Completion of routine/non-routine to more complex projects/assignments. Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP. Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings. Normally receives very little instruction on routine work, general instructions on new assignments. Education and Experience: 4+ years of relevant experience in a GMP environment related field and a BS OR 2+ years of relevant experience and a MS. Prior experience in pharmaceutical industry is preferred (ideally within a QA role). Oral solid dose experience is 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. Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations. Demonstrates audit and investigation skills, and report writing skills. Good verbal, written, and interpersonal communication skills. Proficiency in Microsoft Office applications. Interested candidates should submit an updated CV.
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