DPEM QA Person in Plant-Drug product external manufacturing (Dublin, Ireland) at Eli Lilly and Company Mid-Senior level Not discloses Ireland Limerick, County Limerick, Ireland 20 hours ago At 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 work to discover and bring medicines to those in need, improve disease management, and contribute to our communities through philanthropy and volunteer efforts. We prioritize putting people first and are seeking individuals committed to making a positive impact worldwide. Responsibilities This role provides daily quality oversight at the Contract Manufacturing (CM) site, primarily onsite. Responsibilities include setting up processes for device assembly and packaging, supporting technical transfer until process validation, and providing guidance during routine manufacturing issues such as deviations, change controls, and procedure revisions. The QA Person may also be responsible for final batch disposition, acting as the primary contact for escalation, and ensuring batches meet specifications and comply with cGMP and regulatory standards. Key Objectives/Deliverables Understand the process and equipment for their product scope, including process science, upstream/downstream effects, and failure modes. Support daily operations by developing quality systems, reviewing investigations and changes, and ensuring compliance with GMPs and Lilly standards. Contribute to a quality culture, perform investigations, troubleshoot issues, and support audits and inspections. Assist in batch release activities, including review of batch records, deviations, and issuance of Certificates of Analysis. Maintain material management and support data gathering for compliance reports. Relationships Develop strong working relationships with CMs, QA/QC personnel, and internal teams to ensure adherence to quality agreements and support audits and inspections. Continuous Improvement Identify vulnerabilities and promote process improvements, ensuring quality initiatives are managed through GMP plans. Basic Qualifications Bachelor's Degree in Pharmacy, Chemistry, Engineering, Biological Science, or related field. 3-5 years supporting quality/technical functions in device assembly/packaging. Additional Skills/Preferences Regulatory experience, technical networks, familiarity with Lilly systems (SAP, Trackwise, Q docs), and experience supporting batch release are preferred. Strong knowledge of cGMPs, excellent communication, leadership, and problem-solving skills, and ability to work independently and in a team environment. Additional Information This is a day shift role with potential schedule flexibility. The position requires full-time onsite presence in Dublin, Ireland, with some travel. Lilly is committed to providing accommodations for individuals with disabilities during the application process. #J-18808-Ljbffr
For our client, a software development house based in Cork, we are looking for a QA Manual Tester who will help the team deliver products to the very highest level of quality. This role is suitable for someone who wants to be part of a small but dedicated team of engineers who work on a global platform. This is a permanent position with a hybrid structure in Cork with a possibility to work remotely from within Ireland. Requirements Perform manual testing for web and mobile applications to ensure a seamless user experience Design and maintenance of test plans, test scripts, test cases and data Co‑ordinate all test activities across product owners, scrum masters and developers on all Agile teams to ensure the smooth running of test cycles Liaise with development leads to ensure resolution of system defects Communication with multi‑national teams regarding projects and issues Responsibilities 3+ years of experience in manual testing from a small/midsized company Familiarity with testing frameworks and tools for mobile platforms (iOS and Android) Strong understanding of software development lifecycle (SDLC) and QA methodologies Ability to take ownership for tasks and overcome obstacles Strong interpersonal and facilitation skills with the ability to lead and mentor others on test practices Salary & Benefits Salary: up to €50k p.a. + benefits Please note that we can only accept applications from applicants fully eligible to work in Ireland. #J-18808-Ljbffr
Instrumentation Quality Assurance (QA) Inspector at MSR-FSR, LLC Mid-Senior level Not discloses Ireland Dublin, County Dublin, Ireland 2 days ago Job Title: Instrumentation Quality Assurance (QA) Inspector Location: Ireland (Nationwide) Job Type: Full-Time Department: Quality / Instrumentation / Construction Reports To: QA/QC Manager / Project Quality Manager Job Summary: We are seeking an experienced and detail-driven Instrumentation QA Inspector to oversee the quality of instrumentation installations and testing activities on high-value industrial projects across Ireland. The successful candidate will ensure that all works related to field instruments, tubing, process connections, and control systems comply with project specifications, regulatory requirements, and industry best practices. This role is key to achieving high standards of reliability and compliance in safety-critical environments such as pharmaceutical, biotech, and process industries. Key Responsibilities: • Perform inspections and verifications of instrumentation installations including transmitters, analyser’s, control valves, impulse lines, tubing, and supports. • Ensure compliance with engineering drawings, instrument loop diagrams, P&IDs, IOM manuals, and applicable standards. • Oversee instrument calibration, loop checks, and functional testing in line with project commissioning requirements. • Monitor quality of small-bore tubing installations (e.g., Swagelok or equivalent), ensuring leak-free and compliant assemblies. • Validate installation and documentation of hazardous area instrumentation in compliance with ATEX and IECEx standards. • Review and sign off on quality records including instrument test sheets, calibration certificates, loop folders, and redline drawings. • Identify and report non-conformances, raise corrective actions, and follow through on close-outs. • Support FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and client inspections. • Collaborate with commissioning, construction, and quality teams to ensure coordinated and timely delivery of QA milestones. Qualifications & Experience: • Trade qualification in Instrumentation or Electrical/Instrumentation (National Craft Certificate). or • A Diploma or equivalent in electronic engineering, electrical engineering or manufacturing engineering. • Minimum 2–3 years of experience in instrumentation QA/QC roles on industrial or large-scale construction projects. • Strong understanding of process control instrumentation, loop testing, calibration techniques, and industry best practices. • Familiarity with pharmaceutical, life sciences, oil & gas, or other highly regulated environments. • Working knowledge of I.S. 10101, ATEX Directives, and relevant international standards (e.g., IEC 60079, ISA standards). • Ability to read and interpret P&IDs, loop drawings, instrument data sheets, and control narratives. Desirable: • Valid Safe Pass and Manual Handling certification. • Certification in instrumentation QA/QC or internal auditing (ISO 9001) is an advantage. • Experience using digital QA management platforms (e.g., EIDA, Procore, BIM 360). • Understanding of GMP (Good Manufacturing Practice) requirements for instrumentation installations. Working Conditions: • Site-based role within construction or commissioning phases of industrial projects. • May require work in cleanrooms, live process environments, or at heights. • Use of PPE always required, with strict adherence to HSE policies and site protocols. #J-18808-Ljbffr
Mid-Senior level Not discloses Ireland County Galway, Ireland 19 days ago Mylan Teoranta At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference and here’s how the QA Executive Level II role will make an impact: • Perform detailed batch record review of finished products prior to QP/QA release. • Assist with the maintenance of the incident report system, supplier non-conformance system and the CAPA system. • Perform detailed technical / quality review of all updated artwork. • Approve final printed labelling (where applicable) and update master artwork files and packaging batch records. • Quality Oversight for site Packaging Operations. • Assist in the management of Customer Quality Complaints/Medical Device Vigilance systems. • Prepare monthly/quarterly/annual KPI/Management review data. Prepare annual product quality review reports. Maintain and deliver quality related training to Viatris personnel. • Maintain the companies incoming inspection program. About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: • Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 2-4 years’ relevant experience within a pharmaceutical company with a minimum of 1 years’ experience within a Quality Assurance role. • Experience of sterile manufacturing desirable but not essential. However, a combination of experience and/or education will be taken into consideration. • Knowledge and or experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release. • Experience of Trackwise or similar electronic document management systems is desirable but not essential. • Excellent communication (oral & written) and interpersonal skills. • Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills. • Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (word, Excel, powerpoint etc.) At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. Benefits At Viatris At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary: • Excellent career progression opportunities • Work-life balance initiatives • Bonus scheme • Health insurance • Pension Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr
Not Applicable Not discloses Ireland Limerick, County Limerick, Ireland 64 days ago At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Control Job Category: Non-Standard All Job Posting Locations: IE007 Castletroy Limerick Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Job Description: We are searching for the best talent for the QA/QC Technician 1 role to be in Limerick. Purpose: The QA/QC Technician 1 will be responsible for conducting QC testing and inspections as per QC procedures. The QC Technician 1 role involves the responsibility for equipment verification, sampling of finished goods, secondary package testing, primary package testing, package seal integrity testing, Lens parameter testing and visual audit testing using ‘Laboratory Information Management Systems’ (LIMS). You Will Be Responsible For: • Following Good Manufacturing Practice requirements in all aspects of role • Product testing/ inspection following lab procedures and standards • Collation and entry of results to LIMS (Laboratory Information System) as applicable • Completes record of results as per Good document practices when required • Maintaining QC equipment in a validated GMP state, as per QC procedures • Lens sampling per procedure, as required • Completing QC tasks as directed by QC management • Responsible for completing Training requirements in a timely manner • Responsible for maintaining personal training records in a compliant manner • All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform Qualifications / Requirements: • Level 6 Diploma or degree in Quality or science related discipline • Ability to work on own initiative • Flexible work ethic • Attention to detail • Being able to work in a team environment Join us in shaping the future together—apply now and take the next step in your career with us! #RPOAMS #J-18808-Ljbffr
Not Applicable Not discloses Ireland Athenry, County Galway, Ireland 10 days ago The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Are you seeking to demonstrate your expertise to give to something significant and assist individuals in handling their health? Do you enjoy encouraging and handling relationships to gain a deeper understanding of the business's requirements, and then crafting and implementing solutions to fulfill those requirements? Do you wish to be part of a top-performing team committed to ethical practices? If yes, then we have an opportunity for you! Where You Come In The QA Manager provides support for the projects, functions, and strategic objectives of the Incoming (Receiving) Inspection, Product Release, Quality System Compliance (Audit/CAPA/NCMR) and the document control/training areas. You are a strong tactical decision-maker, handling unforeseen issues as they relate to Dexcom’s compliance with regulations and conformance to required regulations. You regularly interact with senior management or executive levels on matters regarding Dexcom’s compliance with regulations and conformance to required regulations. You exercise supervision in terms of costs, methods, and staffing. You are responsible for the area operational management with a track record of working/supporting high volume manufacturing. You design and maintain the quality system according to written policies and procedures. You understand domestic and international Quality System Requirements and how they interact to be able to provide quality guidance to other departments and companies. Must have the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship. You establish operational objectives and work plans for the Quality Department and delegate assignments. Specifically, assuring your team are meeting sustaining and research and development project deliverables, creating communication between cross-functional departments, participating in process or product investigations, identifying potential root causes and providing business solutions. You utilize quality feedback data from customers, consumers and internal inputs to drive continual improvement activities needed to achieve department strategic goals. Lead the team that manages projects and non-conformance as it relates to the product and processes. Lead management review for the site. What makes you successful: Typically you will have a relevant bachelor's degree or equivalent with 8 - 12 years of industry experience. 2 - 5 years of previous management or lead experience. You review data on product defects, product response plans and product dispositions; recommends and implements improvements. You have knowledge of techniques like six sigma, lean manufacturing, sampling plans and other statistical modelling. You take the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs. What you’ll get: A front row seat to life-changing CGM technology. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 10-15% in 2025, reducing to 5% from 2026 onwards. To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. #J-18808-Ljbffr
QA Specialist-(Batch Release)-Multi Level Mid-Senior level Not disclosed Ireland Limerick, County Limerick, Ireland 15 days ago Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. As a Typical Day May Include The Following: Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance Reviewing of QC related release data, Documentation review Completing deviation, change control & batch record reports to support disposition Performing status labelling of product as the need arises Representing Quality Assurance in support of deviations, CAPAs, etc Representing the IOPS organisation on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications Training & mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organisation Providing consultation or advice in alignment with QA policies Review, edit, or approve controlled documents Interacting with various departments to ensure batch release deliverables are met Evaluating Regeneron processes and procedures with an eye toward continuous improvement This Role Might Be For You If: You have an understanding of biologics manufacturing operations You have excellent organisational skills and attention to detail is essential You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally You have the ability to prioritise multiple assignments and changing priorities You have the ability to learn and utilise computerised systems for daily performance of tasks You have the ability to prioritise, manage multiple tasks, and meet deadlines To be considered for this opportunity you must have a Degree or Masters in a scientific field. Associate Level requires 0-2 years experience, for Specialist level 3 years experience is required and Sr Specialist you must have 5+ years experience directly related experience. 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. #J-18808-Ljbffr
Mid-Senior level Not discloses Ireland Dublin, County Dublin, Ireland 20 hours ago The role: PE Global is currently recruiting for a QA Operations Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract and a 4 cycle shift position. • Shift will be 4 days on, 4 days off with 12 Hour Shifts (7am - 7pm) Description: • The Quality Associate Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements. Responsibilities • Provide direct Quality support to production and support areas. • Provides presence on the shop floor to support compliance and data integrity. • Review and approve GMP documentation/data for accuracy and completeness. • Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors. • QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents. • Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs. • Provides support to internal audits and regulatory inspections. • Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans. Education and Experience: • Bachelor degree, in a scientific or engineering field. • 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function. • Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field. • Technical writing skills. • Lean Six-sigma and problem-solving tools. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** #J-18808-Ljbffr
at Archer - The IT Recruitment Consultancy Mid-Senior level Not disclosed Ireland Dublin, County Dublin, Ireland 29 days ago Job Title: Senior QA Engineer (Manual Testing) – Contract €400-450/Day Location: Dublin Contract Length: 6 months (high potential for extension) Join a Global Leader in Insurance & Technology An exciting opportunity awaits an experienced Senior QA Engineer to join a world-class insurance firm investing heavily in technology and digital transformation. Based in a state-of-the-art IT hub within a newly renovated, modern facility, you will work alongside top professionals on a multi-year Greenfield project. This high-impact role offers the chance to contribute to a company at the forefront of innovation, ensuring quality and excellence in every release. Starting with an initial six-month contract, there is strong potential for long-term extension as the project evolves. Why Apply? Work with a globally recognized insurance leader on large-scale, cutting-edge projects. Be part of a highly skilled, collaborative QA team in a fast-paced, forward-thinking environment. Gain hands-on experience in a modern IT center designed to foster innovation. Take ownership of manual testing strategies, ensuring high-quality deliverables. What You Bring Strong expertise in manual testing, with a keen eye for detail and quality assurance. Hands-on experience with TestRail and Jira for test and defect tracking. Familiarity with Azure DevOps and its role in CI/CD workflows. Basic knowledge of C#, enabling better collaboration with developers and deeper system understanding. Ability to work in a fast-paced, deadline-driven environment, managing multiple priorities effectively. Excellent communication skills, with the ability to liaise with technical and non-technical teams. Bonus Skills (Nice to Have) Experience in the insurance or financial services sectors. Exposure to manual testing tools and frameworks. ISTQB certification or equivalent (advantageous but not essential). Contract €400-450/Day How to Apply If you are ready to be part of a high-impact, fast-moving QA team, we want to hear from you. Apply today by sending your CV to tina.kostaki@archer.ie . We look forward to your application. Job Functions Information Technology and Quality Assurance #J-18808-Ljbffr
