Job Description
QA Specialist AMC22135 11 month contract Hybrid - Carlow Are you passionate about quality assurance and compliance in the pharmaceutical industry? We are offering an exciting opportunity for a QA Specialist to join our clients team in Carlow. You will play a critical role in ensuring the safety and reliability of our vaccines and biologics manufacturing processes. This is the perfect role for someone who has 3-5 years in cGMP environment including at least 2 years in QA. Experience with equipment and process validation a massive bonus. Key Responsibilities: Ensure all manufacturing and support systems comply with cGMP and regulatory standards. Collaborate with cross-functional teams on-site and remotely, providing day-to-day support and project-based advice on communications, training, audits, inspections, investigations, and system compliance. Maintain the sites audit and inspection readiness. Assist in adhering to both divisional policies and regulatory requirements. Act as the site lead for various quality systems (e.g., EDMS, CAPA, Deviations), managing issue resolution and trend analysis. Identify and resolve quality issues promptly and effectively. Provide expertise in implementing quality reporting improvements and fostering continuous improvement within the Quality Management System (QMS). Lead and support quality-related projects, metrics, and communication processes to ensure compliance across departments such as labs, facilities, and validation. What Were Looking For: A Bachelor's degree or higher, ideally in a related science discipline. Knowledge of EU/US pharmaceutical regulations. 3-5 years of experience in a regulated pharmaceutical/biotechnology environment, with a strong focus on aseptic processing, environmental monitoring, and sterile manufacturing. Familiarity with industry best practices for quality and compliance. Experience in FDA/EU-regulated settings, especially in GMP manufacturing. Proven ability to initiate and drive change, with strong project management and communication skills. Experience with equipment and process validation. Proficiency in Microsoft Office and job-related applications. Lean Six Sigma experience (preferred). Strong problem-solving, decision-making, and independent working abilities. If youre ready to bring your expertise to a company that values innovation, diversity, and patient-centric solutions, apply today! Skills: QMS Quality Assurance Validation