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, while enjoying the excellent quality of life in Swords, a vibrant town with both modern amenities and a strong community spirit.

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.

Why Choose Swords, County Dublin?
Swords offers a perfect blend of urban convenience and natural beauty, with a welcoming community, excellent local amenities, and easy access to Dublin city centre.

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.

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

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