About Next Generation

Quality Specialist - QMS - 28ph - Ballydine

Tipperary Cork & Munster

Ref: JOB-14073_1742557805

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. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website.

Tech Transfer Specialist

Cork Cork & Munster

Ref: JOB-14071_1742557292

Are you passionate about cutting-edge vaccine production and eager to take on a key role in technology transfer? We are seeking a Specialist - Vaccines Technology Transfer to join our Technical Operations team. This role is crucial in supporting the seamless transfer and scale-up of new vaccine manufacturing processes, ensuring compliance, efficiency, and high-quality production. What You'll Do: In this role, you will be responsible for leading and supporting key technical activities related to technology transfer, ensuring that new vaccine processes are successfully introduced and optimized. Your responsibilities will include: Technology Transfer & Process Scale-Up: Lead and coordinate activities such as process validation, PPQ batch manufacture, regulatory submissions, and audit readiness. Technical Expertise & Compliance: Ensure all processes meet the highest standards of quality, safety, and compliance with regulatory requirements. Continuous Improvement & Innovation: Stay up to date with advancements in vaccine and biopharmaceutical technologies, identifying opportunities to enhance manufacturing processes through innovation and Lean principles. Problem-Solving & Performance Optimization: Use data-driven decision-making and root cause analysis to troubleshoot issues, streamline operations, and improve efficiency. Collaboration & Stakeholder Management: Work cross-functionally with technical teams, quality assurance, regulatory affairs, and external partners to ensure successful technology transfer and ongoing process improvements. Documentation & Regulatory Support: Contribute to the preparation and approval of technical documents, change controls, deviation reports, and quality notifications. What We're Looking For: We are seeking a highly motivated and detail-oriented professional with the following qualifications and experience: Education: Degree or Master's in Science or Engineering (preferably Biotechnology). Experience: 4+ years in biopharmaceutical or vaccine manufacturing, with experience in process scale-up, validation, or technical projects. Technical Skills: Strong understanding of biopharmaceutical processes, regulatory compliance (FDA/HPRA), and technical problem-solving. Project Management: Experience in managing technical projects, with the ability to coordinate multiple stakeholders and deliver results on time. Lean & Continuous Improvement: Exposure to Lean Six Sigma or other process improvement methodologies is a plus. Software & Systems: Proficiency in data analysis tools and Microsoft Office (Excel, Word, PowerPoint). 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. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website.