Sr QA Validation Specialist
1 day ago
The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory requirements and company standards. As a Sr QA Validation Specialist (IT Infrastructure) typical day might include, but is not limited to, the following: Analysing the results of testing and determines the acceptability of results against predetermined criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to ensure compliance within the operation Leading process improvement projects to improve the qualification of infrastructure platforms Coordinating with other departments or outside contractors/vendors to complete validation tasks Participating in regulatory audits and communicates company's computer validation policies Assessing company's infrastructure platforms and identifies any potential security gaps and ensure the best data integrity practices are implemented Training Specialists and Technicians Technical writing experience Generating, reviewing, and approving of qualification/validation documents Completing risk assessments in relation to IT infrastructure activities Advising and supporting all teams on IT infrastructure and computer systems qualification activities This position might for you if: You have experience with principles of infrastructure and VMware in the Private & Hybrid Cloud domain, as well as an understanding of network infrastructure devices, firewalls and active directory administration You have solid understanding and experience with Computer Systems Validation and/or IT Auditing You have an understanding of the interdependencies of change management, deviation and continuous improvement You have the ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved within required timelines You possess a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211 To be considered for this position you must hold a Bachelor's degree in Computer Science, Information Systems, or a related field with at least 5+ years of experience in IT CSV engineering or a related field. Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Limerick, Ireland Regeneron Pharmaceuticals, Inc Full timeThe individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory...
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Manager QA Validation
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe Manager QA Validation is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Raheen facility. A typical day might include, but is not limited to, the following: Designing and developing policies for validation and ensuring that they are effectively administered and comply...
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Limerick, Ireland Regeneron Pharmaceuticals, Inc Full timeWithin this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...
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Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...
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Validation Specialist
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Limerick, Ireland Life Science Recruitment Full timeWe’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Execute cycle development, cleaning validation and PQ of equipment. 2. Writing and adhering to...
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Limerick, Ireland Analog Devices, Inc. Full timeAnalog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...
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Quality Assurance Associate
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Limerick, Ireland FRS Recruitment Full timePerfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You'll collaborate across departments, manage critical QMS responsibilities, and...
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Limerick, Ireland FRS Recruitment Full timePerfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you’ll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You’ll collaborate across departments, manage critical QMS responsibilities, and...
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Quality Assurance Associate
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Limerick, Ireland FRS Recruitment Full timePerfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You'll collaborate across departments, manage critical QMS responsibilities, and...
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Technical Writer
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▷ Urgent: Instrument Specialist
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Limerick, Ireland PSC Biotech Full timeTipperary, Ireland | Posted on 12/02/2024 - Industry: Pharma/Biotech/Clinical Research - Work Experience: 1-3 years - Country: Ireland Job 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,...
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Limerick, Ireland Cook Medical Full timeOverview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU) This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action...
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Limerick, Ireland Northern Trust Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
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Lead Specialist QC Esystems
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Limerick, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Sr GMP Data Governance
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeIn this role you will be responsible for fostering a culture of data governance (DG) within the site by ensuring compliance with Data Governance policies; designing and delivering relevant training; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in...
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Associate Manager Quality Compliance
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Limerick, Ireland Regeneron Ireland DAC Full timeThis is a leadership role providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Associate Manager Quality...
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Limerick, Ireland PM Group Full timeOverview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are seeking a skilled and motivated...
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Limerick, Ireland PM Group Full timeOverview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are seeking a skilled and motivated...
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Scientist/Sr Scientist/Principal Scientist
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Limerick, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Mechanical Project Engineer
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Limerick, Ireland Jones Engineering H.A. O'Neill Full timePosition: Mechanical Project Engineer Location: Limerick Company Description We are a leading engineering services company with a proven track record of high quality, customer focused project delivery for over 130 years. Our core divisions include Mechanical Engineering, Electrical Engineering, Sprinkler and Fire Protection. Some of the other services we...
