QA Validation Specialist
1 day ago
Are you an experienced QA professional seeking a pivotal role in a dynamic and innovative environment? Join a leading team specialising in Gene Therapy medicinal products, where your expertise in Quality Assurance, Validation, and Qualification will contribute directly to groundbreaking advancements in healthcare. As a QA Validation Specialist, you will play a key role in providing technical support and oversight for the validation and qualification of manufacturing facilities and QC laboratories. Working closely with cross-functional teams, you will ensure compliance with Irish, EU, and FDA regulations while maintaining the highest standards of quality. Key Responsibilities: Develop and maintain the site validation master plan. Oversee the qualification of processes and equipment, ensuring adherence to cGMP and regulatory requirements. Provide training and guidance on validation standards to internal teams and contractors. Review and approve validation protocols, reports, and deviations. Collaborate with engineering, operations, QC, and external partners for seamless execution of validation projects. Support regulatory inspections and third-party audits. Author and maintain SOPs, policies, and work instructions for validation activities. About You: You are a results-driven professional with: A BSc in Science or Engineering. A strong Quality Assurance background in sterile manufacturing within pharmaceutical or biotech environments. Extensive knowledge of GxP compliance and validation requirements, including EU Annex 15, EU Annex 11, and CFR Part 11. Familiarity with cell culture-based manufacturing and gene therapy processes. Exceptional organisational, interpersonal, and communication skills. This is an exciting opportunity to contribute to a cutting-edge facility dedicated to transforming patient outcomes. Be part of a collaborative team in an ambitious, deadline-driven environment where your skills and experience will be valued and rewarded. How to Apply: If you are passionate about quality, innovation, and making a real difference in the field of Gene Therapy, we want to hear from you. Apply today and take the next step in your career Skills: Quality Assurance Validation Qualification Benefits: Negotiable Healthcare Bonus Pension
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FRS Recruitment | QA Validation Specialist
3 weeks ago
Shannon, Co. Clare, Ireland FRS Recruitment Full timeAre you an experienced QA professional seeking a pivotal role in a dynamic and innovative environment? Join a leading team specialising in Gene Therapy medicinal products, where your expertise in Quality Assurance, Validation, and Qualification will contribute directly to groundbreaking advancements in healthcare. As a QA Validation Specialist, you will play...
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QC Validation Specialist
1 day ago
Clare, Ireland Cregg Recruitment Full timeQC Validation Specialist Shannon Co, Clare 6 month contract Requirements: 5+ years of GMP validation experience in biologics or cell and gene therapy Validation of established and novel analytical test methods for the current and newly developed gene therapy products. Generate qualification/validation associated documentation in support of the analytical...
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Validation Specialist Spreadsheet Systems
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Clare, Ireland Cregg Recruitment Full timeValidation Specialist Spreadsheet Systems Shannon, Co Clare 6 month contract Key Responsibilities: Validate Excel-based spreadsheets used in analytical test methods for existing and newly developed gene therapy products. Develop and maintain comprehensive qualification/validation documentation to ensure compliance with GMP and regulatory standards. Support...
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Shannon, Co. Clare, Ireland Cregg Recruitment Full timeValidation Specialist Spreadsheet Systems Shannon, Co Clare 6 month contract Key Responsibilities: Validate Excel-based spreadsheets used in analytical test methods for existing and newly developed gene therapy products. Develop and maintain comprehensive qualification/validation documentation to ensure compliance with GMP and regulatory standards. Support...
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Quality Specialist
1 day ago
Clare, Ireland Cregg Recruitment Full timeJob Title:Quality Specialist Contract Type:Permanent - Days Location:Shannon, Co. Clare Reports To:TBC Requirement:On-Site Job Summary We are seeking a highly skilled and motivatedQuality Specialistto join our clients dynamic team in Shannon. In this role, you will support and enhance the Quality Management System, ensuring compliance with ISO and FDA QSR...
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QA Supervisor
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Clare, Ireland Edwards Lifescience Ireland Ltd Full timeMake a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...
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Quality Director
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Clare, Ireland Harmonics Full timeOur client is seeking an experienced Quality Director to join their dynamic team in Shannon Co. Clare.The purpose of this role is to provide strategic leadership, vision, and direction for the Quality function of the company, ensuring the organisation meets and exceeds its business and quality objectives. PRINCIPAL ACCOUNTABILITIES: Strategic Leadership...
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NPI Specialist
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Clare, Ireland Sterling Engineering Limited Full timeNew Product Introduction SpecialistThe NPI department oversees the development and implementation of new or improved products, collaborating with departments like Production, R&D, Quality, Purchasing, and Test Engineering.Role Responsibilities:• Create product documentation (e.g., labels, packaging, manuals) compliant with local and product standards.•...
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Shannon, Co. Clare, Ireland Cregg Recruitment Full timeJob Title:Quality Specialist Contract Type:Permanent - Days Location:Shannon, Co. Clare Reports To:TBC Requirement:On-Site Job Summary We are seeking a highly skilled and motivatedQuality Specialistto join our clients dynamic team in Shannon. In this role, you will support and enhance the Quality Management System, ensuring compliance with ISO and FDA QSR...
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Ei Electronics | New Product Specialist | ennis
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Ennis, Co. Clare, Ireland Ei Electronics Full timeNew Product Introduction Specialist Employing over 1200 people worldwide, Ei Electronics is headquartered in Shannon, Ireland, occupying a 33,000 m campus where all key manufacturing, R&D and commercial functions are located. Overseas sales and marketing subsidiaries are located in the UK, Germany, France and the USA. The Companys success is based on a...
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Shannon, Co. Clare, Ireland CareerWise Recruitment Full timeNew Product Introduction Specialistrequired for manufacturing client based in Shannon, Co. Clare. As part of the NPI department, you will be responsible for documenting, planning, monitoring and validating changes, as well as creating compliant product documentation in various European languages taking into account the relevant local standards and...
