QA Validation Specialist
2 weeks ago
QA Validation Specialist CREGG are delighted to be recruiting QA Validation Specialists for a leading gene therapy company based in Shannon, Co. Clare. Company Information: Our client is a leading gene therapy company focused on developing innovative treatments for serious diseases. With a global presence and a state-of-the-art manufacturing facility, they are dedicated to advancing gene therapies that have the potential to transform patient outcomes. Role Profile: The QA Validation Specialist will be a key member of our client's team, providing hands-on technical support and oversight for validation activities at their manufacturing facility and QC Laboratories. This role is essential in ensuring that processes and equipment are validated and qualified according to industry regulations while guiding the implementation of the Site Validation Master Plan to support compliance for a new GMP facility. Key Responsibilities: Develop and maintain the Irish site validation plan, ensuring alignment with regulatory and quality standards. Review and approve validation and qualification protocols, discrepancies, and reports. Provide oversight and support for project-related deviations and data integrity compliance activities across the site. Support Regulatory Inspections and third-party audits, ensuring compliance with applicable regulations and internal quality documents. Perform risk assessments and develop robust process validation plans in collaboration with Development, Operations, and QC teams. Qualifications / Professional Skills / Knowledge BSc in Science, Engineering, or a related field. Extensive Quality Assurance background providing QA technical support and oversight to validation and qualification activities within a pharmaceutical or biotech production environment. Thorough understanding of GxP compliance requirements, EU/FDA GMP guidelines, and regulations related to the qualification and validation of sterile products, aseptic processes, and systems. Experience with Computer System Validation (CSV) and familiarity with EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11, and CFR Part 11. Proficiency in risk assessment tools such as FMEA, with the ability to balance business needs against regulatory challenges. Benefits: Competitive Salary. FullHealthcare (Prime cover) for Self & Dependents. Dental Care (DeCare) for Self & Dependents. 25 days Annual Leave Plus Bank Holidays (This is pro-rated depending on start date) Pension Employer contribution of 7.5% if employee contributes 3% or Employer contribution of 4.5% if employee decides wants to opt out. In addition to salary, employee will also be entitled to participate in our discretionary performance-based bonus scheme. Companys share option scheme at a level commensurate with the employees position in the company and individual performance. Contact Information: For a confidential discussion or to find out more, please contact: Brendan McMahon | Recruitment Consultant - Engineering Skills: QA Validation QC GMP GLP GXP Laboratories Benefits: Paid Holidays Canteen Parking Share options Pension Bonus Laya Healthcare
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QA Specialist
2 weeks ago
Carlow Town, Co. Carlow, Ireland Life Science Recruitment Ltd Full timeQA Specialist AMC22135 11 month contract Hybrid - Carlow Are you passionate about quality assurance and compliance in the pharmaceutical industry? We are offering an exciting opportunity for a QA Specialist to join our clients team in Carlow. You will play a critical role in ensuring the safety and reliability of our vaccines and biologics manufacturing...
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QA Validation Engineer
2 weeks ago
Sligo, Co. Sligo, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...
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QA Validation Engineer
2 weeks ago
Dundalk, Co. Louth, Ireland WuXi Biologics Ireland Limited Full timeCompany description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The...
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QA Specialist
2 weeks ago
Dundalk, Co. Louth, Ireland WuXi Vaccines Full timeWuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based. In development is an integrated...
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QA Compliance Specialist
2 weeks ago
Sligo, Co. Sligo, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...
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QA Validation Engineer
2 weeks ago
Sligo, Co. Sligo, Ireland Collins McNicholas Full timeOur client, aglobal healthcare leaderis currently recruiting forQA Validation Engineerto join their growing team inCo Sligo |12 Month Contract. Responsibilities : Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP...
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QA Compliance Specialist
2 weeks ago
Ballina, Co. Mayo, Ireland Headcount Solutions Full timeQA Manufacturing Compliance Specialist (Biologics) rotating day and evening shift An career advancing opportunity has arisen for a QA Compliance Specialist within a Pharmaceutical Manufacturing leader based in the West of Ireland Responsibilities Providing quality and compliance oversight and assistance to the Operations function of the company to...
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QA Technologist
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Dunboyne, Co. Meath, Ireland Next Generation Recruitment Full timeJob Title: QA Technologist Location: County Meath Sector: Food Manufacturing About the Role: A leading food company in County Meath is seeking a QA Technologist to join their growing team. Reporting to the Operations Manager, the successful candidate will be responsible for maintaining and ensuring compliance with BRC standards across the site. This is an...
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Operations Specialist
2 weeks ago
Sligo, Co. Sligo, Ireland Cpl Resources Full timeOperations Specialist - Quality Assurance Biotechnology Manufacturing Sligo Permanent I am looking to speak with candidates that have 3 years in QA function coupled with circa 5 years industry for the newly created role of QA Operations. You will haveknowledge of batch related documentation and activities related to on-going manufacturing including the...
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QA Specialist
2 weeks ago
Bray, Co. Wicklow, Ireland Randstad Client Solutions Ireland Full timeResponsibilities Collaborate with system owners to design and maintain compliant, efficient quality systems supporting GMS and product lifecycle. Oversee data integrity and act as system administrator for key Quality Systems. Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements. Evaluate, approve, and...
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QA Specialist
2 weeks ago
Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full timeThis is an 11 month initial contract. Purpose The role will support quality systems, monitoring and management and will liaise with technical subject matter experts from other company sites as well as participate in above site technical forums. The role will provide technical expertise, troubleshooting, training and support activities to different areas such...
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QA Engineer
7 months ago
Carrick-On-Shannon, Ireland Freudenberg Full timeEmpowering people, creating technology. Responsibilities: Performs routine assignments using existing procedures to solve standard problems Typically requires a college or university degree or equivalent work experience Has conceptual knowledge of fundamental theories, principles and practices Has no related work experience or has work experience...
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Quality Validation Engineer II
2 weeks ago
Athlone, Co. Westmeath, Ireland Medtronic Vascular Galway UC Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...
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Payroll Specialist
2 weeks ago
Dundalk, Co. Louth, Ireland Recruitment Plus Full timeJob Title: Payroll Specialist Location: Dundalk, Co. Louth Job Type: Permanent Reference Number: S011481 Our client is seeking a Payroll Specialist to join their team in a long-standing and thriving multi-discipline accountancy practice. This is an excellent opportunity to work for a company that offers you the chance to advance professionally and exposes...
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Project Manager Cavan
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Cavan, Co. Cavan, Ireland Construction Specialist Recruitment Full timeProject Manager Cavan Our client a specialist in the water and Energy sectors currently have an exciting opportunity for a Project Manager to join their team to start on a solar farm project in Kildare. If you are looking for an opportunity to start you career please apply today. Principal Duties and Responsibilities: Reporting directly to a Contacts Manger...
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Global Head of Quality Assurance
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County Clare, Ireland Cpl Full timeGlobal Head of Quality AssuranceThe Global Head of Quality Assurance is responsible for the overall QA strategy and management of the Quality Assurance team and is responsible for hiring, managing performance, and development of Quality Assurance staff.The individual is recognised as a subject matter expert regarding Quality Assurance practices and...
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Site Manager
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Ballina, Co. Mayo, Ireland Construction Specialist Recruitment Full timePosition: Site Manager / Finishing Foreman Location: County Mayo, Ireland Project: Hotel Refurbishment & Part New Build Contract Type: Full-time (Project-based) Salary: Competitive (Dependent on experience) Start Date: Immediate About the Project: An exciting opportunity has arisen to oversee the refurbishment and part new build of a luxury hotel in County...
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Finishing Foreman
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Athlone, Co. Westmeath, Ireland Construction Specialist Recruitment Full timePosition: Finishing Foreman Location: Athlone, Ireland Contract: Full-time Sector: Educational Construction Project Salary: Competitive, based on experience Company Overview: We are a leading construction company with a strong portfolio of successful projects across Ireland. Our reputation for delivering high-quality educational buildings and facilities...
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QC Specialist
2 weeks ago
Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full timeThis is an 11-month contract and is a hybrid position. Purpose This is a contract-based role for an Associate Quality Control Specialist as part of the Incoming Quality team reporting to the Quality Control Manager. You will support all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other...
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Sterility Assurance Coordinator
2 weeks ago
Sligo, Co. Sligo, Ireland FRS Recruitment Full timeSterility Assurance Coordinator Biotech Scale-Up Join a leading biotech company in an exciting growth phase, working on the forefront of microbiology and cleanroom management currently seeking a Sterility Assurance Coordinator to lead key projects Key Responsibilities: Lead and manage cleanroom upgrades from Grade D to Grade A. Develop and implement action...