Specialist Quality Assurance
6 hours ago
Specialist Quality Assurance The Quality Assurance (QA) Specialist will be an active member of the ADL QA team. The QA Specialist will be assigned to the Incoming Quality Assurance (IQA) functional area, which is responsible for the inspection and release of incoming primary and secondary packaging components and sampling of raw materials. The QA Specialist will report to a QA Senior Manager. In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. Incoming Quality Assurance Specialist Key Responsibilities Act as Quality point of contact for incoming inspection and sampling processes, providing advice to ensure all activities meet internal and regulatory expectations. Oversight of ADL and external Warehouse activities. Manage the introduction of new techniques and equipment to IQA, including method transfers, and validations Assume ownership and/or oversight of change control and Deviation/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely. Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. Participate in product complaint investigations, as required. Provide training and advice to staff in relation to testing of components. Actively participate in audits and their preparation. Evaluate practices for compliance and operational excellence improvement on a continuous basis. Perform all activities in compliance with Amgen safety standards and SOPs Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies, and procedures. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience, and knowledge. Basic Qualifications: University degree - Engineering or Science related discipline preferred. Relevant experience (8+ years) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications: Excellent written and verbal communication skills Experience working with dynamic cross-functional teams and proven abilities in decision making and influencing Strong organizational skills, including ability to follow assignments through to completion Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
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Quality Assurance Specialist
10 hours ago
Dublin, Ireland F. Hoffmann-La Roche AG Full timeQuality Assurance Specialist (2-year FTC) Quality Assurance Specialist (2-year FTC) Locations: Dublin Time Type: Tempo integral Posted on: Publicado há 2 dias Time left to apply: Data de término: 24 de janeiro de 2025 (11 dias restantes para se candidatar) Job Requisition ID: 202501-100480 Roche fosters diversity, equity and inclusion, representing...
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Quality Assurance Technician
6 hours ago
Dublin, Ireland Quorum Search Partners Full timeDue to continued growth, our client now has an exciting opportunity for a Quality Assurance Technician to join their Quality team in North Dublin. This position is ideal for individuals with a strong background in quality assurance, a passion for food safety, and a proactive approach to maintaining high standards. Working Days: 5 days over 7. Hours:...
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Quality Assurance
6 hours ago
Dublin, Ireland PSC Biotech Full time- Industry Pharma/Biotech/Clinical Research - Work Experience 4-5 years - City Dublin - State/Province Dublin - Country Ireland Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US,...
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Quality Assurance Manager
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Dublin, Ireland Amarin Corporation Full timeQuality Assurance Manager Quality Assurance Manager Apply locations Dublin, Ireland time type Full time posted on Posted 30+ Days Ago job requisition id JR620 At Amarin, you’ll make a difference. Our vision is to one day reach the moment when heart disease is no longer the #1 cause of death in Europe. Bold, we know. But it’s what drives us every...
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[15h Left] Quality Assurance Technician
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Dublin, Ireland Quorum Search Partners Full timeJob Opportunity: Quality Assurance Technician Location: North Dublin. Please note a full valid driver's licence & access to a car is essential for this role as the site is not accessible by public transport. Reports To: Technical Manager Working Hours:7.15am to 3.45.pm. Weekend work involved. Negotiable salary: €35k DOE Are you passionate about quality and...
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Dublin, Ireland The National Screening Service Full timeAbout us The National Screening Service (NSS) delivers four national population-based screening programmes for cervical, breast and bowel screening and for detecting sight-threatening retinopathy in people with diabetes. Our programmes focus on looking for early signs of disease in healthy people, so that we can: detect health issues early help prevent...
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Senior Quality Assurance Manager
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Dublin, Ireland LINCOLN RECRUITMENT Full timeJob Title: Food Quality Assurance Officer Our client is seeking a dedicated and experienced Food Quality Assurance Officer to join their team in Ballymount, Dublin. This role offers the opportunity to contribute to the continuous improvement of food safety standards across their operations. The successful candidate will work closely with various departments...
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Quality Assurance Operations
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▷ 3 Days Left: Quality Systems Compliance Specialist
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Dublin, Ireland PSC Biotech Corporation Full timeJob Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
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▷ High Salary: Senior Quantity Surveyor Swords
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QA Specialist New
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Dublin, Ireland CPL Full timeCpl in partnership with our client Pfizer are seeking QA Specialist to join the team for an 11 month fixed term contract in their state of the art site in Dublin, Grange Castle. Depending on shift working, this is an onsite role. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will...
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IPS EMPLOYMENT SPECIALIST
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Dublin, Ireland Rehab Group Full timeA commitment to living the values of Teamwork, Respect, Dignity, Justice, Advocacy and Quality. We are an independent voluntary organisation providing services and support for people with disabilities and their families for more than 70 years. Our work positively impacts the lives of over 10,000 people with disabilities, equipping them with the confidence,...
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Senior Project Manager
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Dublin, Ireland SSE Renewables Holdings Airtricity Full timeSSE has big ambitions to be a leading energy company in a low carbon world. Following our commitment to invest £20.5 billion in low carbon projects to 2027, we have significant growth plans and are well on our way to achieving our ambition to build a world that's more sustainable and inclusive for you, your family, the community you live in and for...
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QA System and Validation Specialist
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Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
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QA System and Validation Specialist
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Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
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Health & Safety Advisor - Dublin
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Clinical Specialist Radiographer CT
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Website Audit Specialist
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Dublin, Ireland Recruitment by Aphex Group Full timePurpose We are seeking a highly detail-oriented Web Site Audit Specialist to conduct a comprehensive audit of our career site, which includes over 1,000 landing pages. This is a crucial role responsible for ensuring the accuracy, functionality, and consistency of all site elements. The ideal candidate will meticulously review each page, including links,...