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 & Compliance
1. Act as a subject matter expert (SME) in Quality Systems, including investigations, change management, and sterility assurance.
2. Provide quality approval and oversight for commissioning and qualification activities (IQ/OQ/PQ).
3. Ensure compliance with regulatory requirements and contribute to regulatory inspections and audits.
Problem Solving & Continuous Improvement
4. Apply your knowledge to enhance Quality Systems, resolve complex issues, and drive process improvements.
5. Participate in GMP walkthroughs and champion a culture of compliance and quality excellence.
6. Support corporate quality initiatives and ensure site-wide execution of quality actions.
Collaboration & Leadership
7. Provide guidance and coaching to colleagues, sharing expertise in operational quality.
8. Lead small projects and contribute to cross-functional teams.
9. 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.