Job Description
Job Title : Quality Assurance Specialist Location : Cork Contract Type: 12 Months Job Description: Our Pharmaceutical client is currently hiring for a QA Specialist on a 12 month contract. The role will require performing QA review of manufacturing and strong understanding of QA systems, procedures and methods. The ideal candidate Will have previous experience within a QA role in the pharmaceutical industry as well good decision making skills, ability to identify problems and provide the correct solutions within a well-defined process. Key Responsibilities and Duties: Conducts various activities to ensure adherence to relevant cGxP regulatory requirements. Reviews manufacturing, QC, and engineering documents, including batch manufacturing records. Supports the investigation of customer complaints related to manufacturing processes. Involved in drafting, reviewing, and approving Standard Operating Procedures (SOPs) and other controlled documents. Identifies deviations from standard practices, evaluates their impact, and determines corrective actions. Reviews and approves GMP deviation investigations and CAPAs. Detects issues, proposes alternatives, and provides recommendations. Manages both routine and more complex projects or assignments. Conducts internal audits and walkthroughs on behalf of the QA department to ensure GMP site compliance. Contributes to Strategic, Technical, and Operational Excellence projects for the site on behalf of QA, and represents QA in cross-functional meetings. Works independently on routine tasks, requiring minimal guidance, and receives general direction on new assignments. Qualifications and Skills: Previous experience in the pharmaceutical industry is preferred (ideally in a QA role). Solid understanding of current Good Manufacturing Practices (cGMPs) and familiarity with FDA/EMEA standards and quality systems. Strong knowledge of quality assurance systems, processes, and procedures. Basic understanding of OPEX Lean tools and root cause analysis for resolving deviations. Proficient in audit and investigation techniques, as well as report writing. Strong communication skills, both verbal and written, with good interpersonal skills. Skilled in using Microsoft Office applications. 4+ years of relevant experience in a GMP environment related field and a BS. 2 + years of relevant experience and a MS. Resilient and ability to deliver in a challenging environment KSGalway Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Recruitment Ireland Limited and Kelly Services (UK) Ltd. Gi Group Recruitment Ireland Ltd are acting as an Employment Business in relation to this role. We are committed to protecting the privacy of all of our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website. Skills: QA pharmaceutical Quality