Quality Specialist - Quality Systems Are you a quality-driven professional with a passion for compliance and continuous improvement?
We are looking for a Quality Specialist - Quality Systems to provide expert oversight and support across site operations.
This role is embedded in production, ensuring a strong Quality Management System that meets the highest industry standards.What You'll Do: Quality Oversight & ComplianceAct as a subject matter expert (SME) in Quality Systems, including investigations, change management, and sterility assurance.Provide quality approval and oversight for commissioning and qualification activities (IQ/OQ/PQ).Ensure compliance with regulatory requirements and contribute to regulatory inspections and audits.
Problem Solving & Continuous ImprovementApply your knowledge to enhance Quality Systems, resolve complex issues, and drive process improvements.Participate in GMP walkthroughs and champion a culture of compliance and quality excellence.Support corporate quality initiatives and ensure site-wide execution of quality actions.
Collaboration & LeadershipProvide guidance and coaching to colleagues, sharing expertise in operational quality.Lead small projects and contribute to cross-functional teams.Manage relationships with key stakeholders, auditors, and regulatory bodies.What We're Looking For:? Education: Degree or 3rd level qualification in Science, Quality, or related field.? Experience: 5+ years in the pharmaceutical or similar regulated industry, with expertise in Quality Assurance.? Technical Skills: Strong understanding of regulatory compliance, quality systems, and pharmaceutical manufacturing processes.? Soft Skills: Excellent problem-solving, decision-making, and stakeholder management abilities.? Bonus: Experience leading small projects and applying continuous improvement methodologies.