Quality Specialist - QMS - 22465 - 35ph - Brinny
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
* Act 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 Improvement
* Apply 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.
* Provide 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.
The Next Step for you:
Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
Applications are in strict confidence.
Next Generation will never share your data outside of our organisation without your prior written consent.
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