We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. 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. Ideally the person will have general test methods product samples, such as pH, appearance, colour, clarity, protein concentration, moisture, etc., along with technical writing experience. This person needs to have experience planning and performing multiple, complex routine/non-routine methods & procedures, and should have conducted lab investigations within a biopharmaceutical, pharmaceutical or medical device industry. Duties: Plan and perform analyses with great efficiency and accuracy. Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays. Report, evaluate, back-up/archive, trend and approve analytical data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents. Participate in audits, initiatives and projects that may be departmental or organizational in scope. Review protocols and perform assay validation and equipment qualification/ verifications when required. Introduce new techniques to the lab, including method transfers, reports, validations and protocols. May contribute to regulatory filings. May conduct lab investigations as necessary. Evaluate lab practices for compliance on a continuous basis. May interact with outside resources. LIMS data coordination of commercial and import testing on site where applicable. May represent the department/organization on various teams and may train others. Education and Experience: Hold a Bachelor’s degree in a Science related field is required. 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry. Have strong technical writing skills (e.g. updating SOP) and investigation skills. Experience with analytical techniques such as Compendial testing would also be advantageous. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. If interested in this posting please feel free to contact Avishek Singh at Avishek.singh@lifescience.ie or 0872827991 for further information. Seniority level Associate Employment type Contract Job function Science Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr
Associate Director - Global Core Labeling (Regulatory Affairs) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre. The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components. The Associate Director ensures timely delivery of global labeling to our clients affiliates to facilitate simultaneous global submissions. Additionally, the Associate Director leads timely updates and communication of core labeling changes throughout the product lifecycle. Primary Responsibilities: Global Labeling Leadership Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions. Implement “Accelerate Reach and Scale” initiatives related to global labeling strategy. Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners. Core Labeling Development and Maintenance Lead the development and maintenance of core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL) that includes Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content]. Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC). Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary. Lead the development and maintenance of clinical trial Instructions for Use. Labeling Process Excellence Optimize core labeling exception process. Manage core labeling exception requests and facilitate approval from leadership. Support periodic labeling assessments to assess compliance of affiliate product information with core labeling. Serve as subject matter expert for core labeling. Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes. Anticipate and resolve key technical or operational issues that can impact labeling development and timelines. Develop and present metrics to governance and other forums to monitor and improve the labeling exception process. Lead/Influence/Partner Exemplify the Team behaviors of Include, Innovate, Accelerate, and Deliver. Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers. Participate in forums that share regulatory information across GRA components and other teams and business partners. Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy. Ensure timely communication of global labeling to global affiliates. Partner with Labeling Implementation Associates to ensure local labeling aligns with core labeling. Minimum Qualification Requirements: Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience). Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years. Demonstrated knowledge of the drug development process and regulatory/business strategies. Demonstrated ability to assess and manage risk in a highly regulatory environment. Demonstrated ability to lead, influence and partner cross-functionally. Demonstrated strong communication skills: writing, presenting, listening. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles. Demonstrated attention to detail and organizational skills. Ability to learn and use new software/technology. Ability to manage multiple tasks simultaneously. For further information please contact: Karen Shiel on 087 7452487 or send CV in confidence to karen.shiel@lifescience.ie #J-18808-Ljbffr
Social network you want to login/join with: Senior QA Specialist RK 3740 Contract – 12 months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. 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. Responsible for product release, ensuring products meet cGMP specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Duties: • Reviewing batch documentation and product release • Conducting and participating in manufacturing investigations. • Reviewing and approving EM deviations • Developing corrective action plans and monitoring implementation • Review and approve change control • Writing and implementing of quality procedures • Identifying and implementing continual improvements of manufacturing and quality/compliance processes • Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time • Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation • Participating in quality audits at external manufacturers • Monitor quality trends, identify issues, recommend and implement appropriate actions to mitigate risk. • Participate and support escalation process and issue management process • Support regulatory inspections, manage reporting and monitor follow up on regulatory commitments • Maintain Quality Agreement and specification changes. • Responsible for continuous improvement and risk management Experience and Education: • A degree is required with a focus in engineering, science or equivalent technical discipline • 6 years of relevant work experience • Knowledge of Quality Assurance, Quality Control and Compliance If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [emailprotected] for further information. #J-18808-Ljbffr
Senior Associate Quality for Computer Systems Senior Associate Quality for Computer Systems Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Life Science Recruitment A Senior Associate Quality for Computer Systems is required to join a global cutting-edge biotechnology company in Limerick. You will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within this next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. The Role Develop and maintain quality assurance procedures, policies, and systems. Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations. Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process. Investigate and address deviations, non-conformities, and CAPA to maintain quality. Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems. Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes. The Person BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline. Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment. Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements. Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus Excellent problem-solving and analytical skills. For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie Seniority level Seniority level Associate Employment type Employment type Full-time Job function Job function Quality Assurance and Information Technology Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Life Science Recruitment by 2x Get notified about new Quality Assurance Specialist jobs in County Limerick, Ireland . Limerick, County Limerick, Ireland 48 minutes ago Limerick, County Limerick, Ireland 3 days ago Limerick, County Limerick, Ireland 3 days ago Internal Audit Training & Quality Assurance Specialist Limerick, County Limerick, Ireland 6 days ago Internal Audit Training & Quality Assurance Specialist Limerick, County Limerick, Ireland 3 weeks ago DPEM QA Person in Plant-Drug product external manufacturing (Dublin, Ireland) Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 5 days ago Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 3 weeks ago Principal GMP Data Governance Specialist Limerick, County Limerick, Ireland 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Social network you want to login/join with: We’re currently recruiting for an exciting opportunity with a quality assurance professional to join a chemical manufacturing organization based in Cork. Duties Act as a liaison on safety, assist in review of health and safety strategies, and develop internal policies. Encourage and motivate the team to understand and implement food safety, integrity, and quality practices adhering to customer and international standards in housekeeping, quality, health, and safety. Assist in closing out and resolving customer complaints and inquiries related to the site QMS. Provide quality oversight for calibration and maintenance programs. Conduct administrative tasks for process and product risk assessments. Keep plant and senior management fully informed of any issues and assist in achieving quality and compliance goals. Develop, write, and maintain protocols and reports. Ensure site-based compliance for certifications such as Halal, ISO, and FSSC. Education & Experience Level 6 qualification or higher in a chemistry, microbiology, or food science-related area. Strong understanding of HACCP and other food safety management systems is desirable. Understanding of Food Safety Standard Certification procedures and processes, Environmental Management Systems is desirable. Experience in quality assurance, preferably in ingredient manufacturing. If interested in this posting, please contact Seán McCarthy at +353 (0)87 798 8480 or email [email protected] for further information. #J-18808-Ljbffr
An SAP Analyst - Logistics & Supply Chain is required to join a leading global Biopharmaceutical business based in Limerick. This is a fantastic opportunity to join a global business focused on developing and manufacturing breakthrough medicines. This is a fully site-based role on a brand new technically advanced manufacturing site. The role will support the business processes and systems for the manufacturing site's inbound, internal, and outbound logistic flows. The role will provide analyst support for an integrated set of systems that includes SAP S/4HANA and SAP Extended Warehouse Management (eWM). The Role Understand the S4 Hana and EWM systems and equipment involved in logistics operations and material control including the associated data and data flows. Provide support to the Site Supply Chain and Logistics teams on how to resolve business user requests and issues. Understand how the logistics systems and processes integrate with other critical systems like MES (Manufacturing Execution System) and Process Automation e.g. ASRS (Automatic Storage and Retrieval System). Build expertise in the SAP eWM technology and its integration to additional SAP Supply Chain modules. The Person Bachelor’s Degree in Information Technology, Computer Science, Engineering or related field (Level 8 or equivalent). 5+ years of experience in manufacturing, preferred in pharmaceutical or other regulated industries. Experience with integrated logistic flow in a manufacturing facility, including prior experience with SAP or equivalent ERP systems. Knowledge of System Development Life Cycle. cGMP experience is highly desirable. For further details please contact Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie. #J-18808-Ljbffr
Our client, an early-stage company developing innovative medical device technology, is looking to expand the team to support its development and manufacturing activities with the recruitment of a Quality Manager. Reporting to the COO, the Quality Manager will be responsible for the quality system, quality aspects of internal manufacturing, oversight of sub-contract manufacturing partners, and support of internal projects. Role/ Responsibilities: Maintain the company's Quality Management System (QMS) and report on the performance of the QMS to the company's Senior Management Team. Supervise Quality Technicians and Quality Engineers. Lead quality personnel in the completion of required departmental activities including objectives/ goals. Quality system oversight: management reviews, quality review, and internal audit programme. Supplier control including: supplier audits, SCARs, performance monitoring, and quality agreements. Manufacturing validation including: MVP development, PFMEAs, validation protocols, and reports. Customer complaints: approval of analysis reports and analysis of complaint trends. CAPA/NCR: oversight of the investigation and timely closure of CAPA and NCRs. Lot release: Routine sterilisation and lot release. External audits: lead the company in regulatory agency quality management system audits including FDA and Notified Body. Operations support: provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost, and output. Communicate with all functional groups to ensure awareness of quality requirements. Update the QMS to meet evolving regulatory and business requirements. Skills & Experience: Bachelor's in a scientific discipline required with 4 years’ experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills, or a combination of relevant work experience and education. Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements. Ability to work as part of a team and meet targets/goals efficiently. Demonstrated organisational, management, and communication skills. Good interpersonal & communication skills essential. Strong knowledge of quality principles and the ability to utilize these methods in development and manufacturing environments. For further information please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence 086 0204322. #J-18808-Ljbffr
1 month ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Life Science Recruitment Head of Life Science at Life Science Recruitment Quality Director – Medical Device Start-Up – Galway About the Company Our client is a dynamic, well-funded medical device start-up based in Galway, poised for significant growth as it moves further into the operational space. Led by a highly experienced management team with a proven track record of success in the start-up ecosystem, the company is entering an exciting phase of expansion and scale-up. The Opportunity We are seeking a Quality Director with strong strategic vision and leadership capabilities to join the executive team. This is a pivotal role where you will shape and execute the company's quality strategy, oversee regulatory compliance, and drive operational excellence as the business grows both domestically and internationally. Key Responsibilities Lead the development and execution of the company’s Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable standards and regulations. Partner closely with Operations, R&D, Regulatory Affairs, and Commercial teams to support product development, manufacturing, and market launch activities. Build and scale quality systems to match the company's growth trajectory, including internal and external auditing, supplier quality management, and CAPA systems. Develop and mentor a growing quality and regulatory team, fostering a culture of quality throughout the organization. Contribute to the broader strategic direction of the company as part of the senior leadership team, providing input on expansion initiatives and operational scale-up. Serve as the main point of contact with regulatory bodies during inspections, audits, and certification processes. About You Minimum of 10 years’ experience in Quality Assurance within the medical device industry, with at least 3 years in a leadership role. Deep knowledge of international medical device regulations and standards. Demonstrated ability to build, implement, and evolve scalable quality systems in a growing organization. Strategic thinker with strong leadership, communication, and team-building skills. Comfortable working in a fast-paced, entrepreneurial environment. Experience supporting product commercialization and operational expansion is highly desirable. Degree in Engineering, Science, or a related technical field; advanced degree preferred. What’s on Offer An opportunity to shape the future of a high-potential medical device start-up. A senior leadership role with influence across the entire organization. Competitive salary, equity participation, and comprehensive benefits package. A collaborative, ambitious environment with a leadership team known for successful start-up growth and exits. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Quality Assurance and Engineering Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Life Science Recruitment by 2x Galway, County Galway, Ireland 4 days ago Director of Quality Assurance & Regulatory Affairs Galway, County Galway, Ireland 6 days ago Galway, County Galway, Ireland €55,000 - €65,000 2 weeks ago Galway, County Galway, Ireland 1 week ago Quality and Safety Coordinator Grade VII Grád VII Women’s and Children’s WandC Managed Clinical and Academic Network MCAN SG321 Galway, County Galway, Ireland 1 week ago Galway, County Galway, Ireland 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
A Quality Manager is required to join a leading manufacturing business based in County Wexford. Leading the Quality Team, you will be instrumental in overseeing and enhancing the company's quality management system and quality assurance protocols. This role is pivotal in ensuring that all products and processes meet stringent industry standards including food, wastewater utilities and pharmaceutical industry standards, particularly focusing on product inspection and verification along with validation processes, regulatory inspections, customer audits, and independent regulatory audits. A robust approach to Corrective and Preventive Action (CAPA) management and fostering a culture of continuous improvement is a key aspect of the role. The Role Develop, implement, and maintain quality assurance policies and procedures aligned with customer’s needs, industry standards and regulatory requirements. Oversee auditing, testing and validation activities, including equipment qualification, process validation, and metal finishing and cleaning validation, ensuring compliance with Good Manufacturing Practices (GMP). Coordinate and manage internal and external audits, facilitating both customer and regulatory inspections, and ensuring timely resolution of any findings. Lead the CAPA program by identifying root causes of non-conformances, implementing corrective actions, and verifying their effectiveness. Promote a culture of continuous improvement by implementing Lean methodologies and Six Sigma principles to enhance process and product quality along with operational efficiency. This should be heavily weighted toward visual standards, quality training, inspection skills training, and continuous reviews of Inspection criteria and capability. The Person Bachelor’s degree in engineering, science, quality management, or a related field. Minimum of 5 years' experience in a quality management role within the pharmaceutical equipment manufacturing or related or equivalent general manufacturing industry such as Agri, Automotive or Aerospace. In-depth knowledge of GMP, ISO 9001:2015, and ISO 14001:2015 standards and GDP. Proven experience with Quality assurance management, CAPA management, and regulatory inspections. Excellent project management skills. Strong analytical skills with the ability to interpret complex data to identify problems and drive actionable corrective actions to resolve systemic problems. Excellent communication and interpersonal skills, capable of leading cross-functional teams and interacting with regulatory bodies. Proficiency in quality management software and Microsoft Office Suite with a particular expertise around excel would be advantageous. For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie #J-18808-Ljbffr
Social network you want to login/join with: col-narrow-left Client: Life Science Recruitment Location: Galway, Ireland Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: b8e3a2f651cc Job Views: 4 Posted: 01.06.2025 Expiry Date: 16.07.2025 col-wide Job Description: JOMAXAB-562538 R&D Manager Photochromic and Liquid Crystal Technology You will be part of the world leader R&D organisation in photochromic technology. As R&D Manager, you will lead a dedicated team of scientists and engineers. The team is responsible for developing alternative technologies and manufacturing methods to combine photochromic and liquid crystal technology. You will be leading R&D projects to push the boundaries of the most innovative family of products in the optical sector, combining excellent photochromic performance and adaptive polarization. Key Responsibilities of the Role Manage the Transpolar Technologies team (4-10 scientists and engineers) as part of the R&D Core-Technologies. In close collaboration with the Lead Scientist, define and lead the research and development for the team. Discover, develop, and implement new technologies for photochromic products. Mentor, coach, and ensure that career development plans are in place for direct reports. Plan projects, report progress results, create and maintain all necessary documentation. Work together with the leadership team in R&D to define priorities and contribute to the innovation roadmap. Grow and nurture cross-site and cross-functional relationships in a large, multi-site, matrixed organization. Manage the network of collaborations with scientific institutions. Collaborate efficiently cross-functionally. Ensure a successful transfer of process and product knowledge from R&D to Industrialization. Prepare and present results in international conferences and internal meetings. Key Requirements Master Degree in Chemistry, Chemical Engineering, Materials Science or similar technical degree. A minimum of 5 years of managerial experience leading R&D teams for new product development. Excellent team building, communication, people management and leadership skills. Excellent communicator and fluent in English, both in writing and speaking. Understanding of photochromic and liquid crystal technology. Desirable MBA or relevant managerial experience in R&D. Experience developing products within the optical industry. Understanding of the fundamentals of applied optics. Hands-on with laboratory work and process development. Experience with Design Control for New Product Development. Contact Joan O’Malley at 087-1897333, [emailprotected] for more details. #J-18808-Ljbffr
