Job Title: Quality Control Specialist II (QC Instrumentation Systems)
Location: Swords, County Dublin, Ireland
Contract Role
Are you an experienced Quality Control Specialist with a background in pharmaceuticals? Our client, a global biotech leader, is looking for a Quality Control Specialist II to join their team in Swords, County Dublin. This role offers the chance to manage and optimise QC systems in a high-performing environment.
Key Responsibilities:
QC Systems & Product Release
* Manage the qualification, maintenance, and integration of QC systems, ensuring compliance with data integrity, regulatory standards, and industry benchmarks.
* Oversee the release of incoming goods, outsourced production, and packaging, ensuring all products and processes meet quality procedures, legal guidelines, and market authorisations.
* Communicate quality requirements to suppliers, ensuring the introduction of materials to the site is compliant with documentation and local regulations.
Troubleshooting & Process Improvement
* Act as a subject matter expert (SME) for the QC team, supporting troubleshooting, investigations, and deviations.
* Manage deviations, CAPAs, and change controls, prioritising tasks according to business needs.
* Drive improvements in quality-related issues, ensuring optimal product and process quality.
Audit Support & Compliance
* Serve as an SME for regulatory and internal audits, ensuring QC processes meet compliance standards.
* Maintain and improve local Standard Operating Procedures (SOPs) and guidelines to ensure best practices in QC systems.
Collaboration & Communication
* Work closely with cross-functional teams to ensure projects are delivered on time and within budget.
* Ensure good documentation practices and communicate quality requirements clearly and effectively.
Experience, Knowledge & Skills:
Education & Experience
* Bachelor’s degree in Engineering, Biological Science, or related field.
* Minimum 3 years’ experience in CSV/CQV for laboratory systems within the pharmaceutical industry.
Technical & Business Skills
* Pharma experience required, with a strong understanding of biologics, GMP, and regulatory audits.
* Excellent communication, organisational, and problem-solving skills.
* Experience with change management and validated systems.
Leadership & Collaboration
* Ability to manage multiple projects, meet deadlines, and work both independently and in a team.
* High level of self-motivation and commitment to continuous improvement.
About the Company
Our client is a leader in biotech, committed to innovation and delivering high-quality healthcare solutions globally. Join a diverse, collaborative team dedicated to making a difference.
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