Quality Specialist - QMS - 28ph - Ballydine

Quality Specialist - Quality Systems

Are you passionate about quality and compliance in pharmaceutical manufacturing? We're looking for a Quality Specialist - Quality Systems to support quality assurance activities across both Drug Substance and Drug Product facilities. This is a key role ensuring compliance, process validation, and continuous improvement to maintain the highest standards of pharmaceutical production.

What You'll Do:

As part of the Quality Systems team, you will:

🔹 Ensure Compliance & Quality Excellence

• Oversee key quality systems, ensuring compliance with industry regulations and internal policies.
• Act as the subject matter expert (SME) for validation processes, change control, and quality agreements.
• Support internal audits, regulatory inspections, and quality council meetings.

🔹 Lead & Support Validation and Change Control

• Participate in validation committees for process, cleaning, water, and equipment.
• Approve validation documents, ensuring compliance and ongoing process improvements.
• Provide quality oversight for change control processes, ensuring robust assessments and approvals.

🔹 Support Laboratory & Supplier Quality

• Provide quality oversight for laboratory systems, including stability reports and incident investigations.
• Act as a key liaison for microbiology-related quality concerns.
• Review and approve supplier change evaluations and technical agreements.

🔹 Drive Continuous Improvement

• Monitor and enhance quality systems to improve efficiency and compliance.
• Implement best practices in validation and pharmaceutical quality assurance.
• Contribute to a culture of quality, teamwork, and operational excellence.

What We're Looking For:

✔ Education: Degree or post-graduate qualification in Science, Pharmacy, or Engineering.
✔ Experience: Strong knowledge of pharmaceutical quality systems, GMP standards, and validation principles.
✔ Technical Skills: Familiarity with laboratory testing, plant operations, and quality documentation.
✔ Soft Skills: Excellent communication, problem-solving, and stakeholder management skills.
✔ Bonus: Experience with Lean Six Sigma or process 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.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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