QA Specialist required for a Leading Biotech facility in Carlow, responsible for ensuring that the process for the manufacture of vaccines and biologics and supporting systems are in compliance with cGMP and the associated regulatory requirements. Initially an 11 month contract. Please contact Claire x 105 The QA Specialist will be responsible for ensuring that the process for the manufacture of vaccines and biologics and supporting systems are in compliance with cGMP and the associated regulatory requirements. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers. Partner with colleagues cross functionally/ on and off site to provide support and advice on day-to-day basis and on a project, basis including communications, training, project work, audit/inspection duties, investigations, systems compliance etc.; thereby ensuring department/site is audit/inspection ready. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and procedures as well as regulatory requirements. The ideal candidate will have 4 year's experience in a pharmaceutical/ regulated background with strong working knowledge of regulatory expectations, aseptic processing, environmental and utility monitoring in a sterile manufacturing facility. The role will support quality systems activities and will liaise with site to ensure systems are maintained and compliant as per global and local procedures. Bring energy, knowledge, innovation to carry out the following: Responsible for helping to ensure that the quality systems in use on site maintains complaint status. Act as quality support for site for relevant systems Ensure that quality issues are identified, addressed and resolved in a timely manner. Responsible for supporting issue close out on site and initiating/following up on corrective and preventative actions and continuous improvements. Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations etc Requirements: Bachelor Degree or higher preferred; ideally in a related Science discipline Demonstrated ability in quality systems support Knowledge of EU/US quality related pharmaceutical regulations Experience of Sterile manufacture preferred A minimum of 4 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality system role Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices requirements. Knowledgeable in Industry Best Practices for quality and compliance related topics Proven ability to effectively initiate and drive change Strong verbal and written communication skills, project management skills Report, standards, policy writing skills required Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems) Lean Six Sigma Methodology experience desired Skills: Quality Assurance Pharmaceutical Sciences