Quality Specialist
7 days ago
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Quality Specialist - QMS - 28ph - Ballydine, TipperaryClient:Next Generation
Location:Ballydine, Tipperary
Job Category:Other
EU work permit required:Yes
Job Reference:894c027ad3d2
Job Views:2
Posted:24.03.2025
Expiry Date:08.05.2025
Job Description: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.
- 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.
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