Quality Specialist - Quality Systems
You are a quality-driven professional with a passion for compliance and continuous improvement. We seek 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.
Key Responsibilities:
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.
Collaboration & Leadership
* 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.
Requirements:
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.