Quality Control Specialist The QC specialist will work as part of the integrated QC NPI and Network Testing team and drive a culture of quality and operational excellence within the team. The QC specialist will oversee and manage the site QC readiness activities associated with New product introductions, Testing performed on site on behalf of the wider Network and Testing performed at Network testing labs in collaboration with our global stability team. What you will do: Lead QC NPI and network testing activities, including NPI demand planning across internal and external networks, cross-site coordination, and implementation of QC NPI requirements to support product testing portfolio in accordance with regulatory expectations Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for testing to be performed at on behalf of the site Coordination of testing activities performed across both internal and contract testing facilities , investigating out of specification/ out of trend results, and communication with integrated project teams for biologics, vaccines, and/or devices Ensure the Lab sample management and reporting procedures, together with associated systems ( e.g GLIMS/ SAP) are maintained to Support NPI and Network testing requirements. Execute deviations and investigations, Change Management records, manage GMP documentation including GLIMS updates, Standard Operating Procedures (SOP), and GMP data management. Support authoring and approval of Annual Product Review Support document requirements for new product registrations and batch reallocations Assessment of network testing impact as a result of Pharmacopeia and Quality standard updates Lead and participate in improvement projects and QC Hoshins within the area. What skills you will need: In order to excel in this role, you will more than likely have: 3-5 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a QC function. Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines. Degree in Science, Engineering or similar Knowledge of cGMP in Laboratory Quality Systems. Knowledge of laboratory testing regulatory requirements. Proficiency in Microsoft Office and job-related computer applications required. Demonstrated experience in Report, standards, policy writing. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Good communication, interpersonal skills and ability to work across teams. Has experience in elements of the lean toolkit including value stream and process mapping, standard work, tier process, problem solving, Leader Standard Work, 5S work place organization, Strategic A3 thinking, Hoshin Kanri, managing change, 8 wastes identification, poka yoke and Kanban. Demonstrated ability to drive the completion of tasks. Proven decision-making capability with accountability and responsibility. Demonstrated ability to solve problems.
QC Micro Technician (Carlow) Join our team in a dynamic Microbiology laboratory as a QC Micro Technician. We are looking for an enthusiastic and hard-working individual with strong attention to detail, problem-solving skills, and the ability to work independently or as part of a team. This is an exciting opportunity to contribute to our mission of delivering innovative health solutions. Responsibilities Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities. Perform laboratory testing to determine specification conformance and to support site targets, including but not limited to bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. Maintain an adequate, qualified, and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements. Contribute to effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality related systems. Highlight any discrepancies, deviations, or non-conformance in testing or work practices and support investigations as required. Ensure compliance with GMP and EHS guidelines at all times. Participate in training programs as required. Qualifications Required Minimum of Bachelors Degree or higher in a related Science discipline 1-2 years' experience in a GMP laboratory environment Good knowledge of GMP, GLP, and aseptic technique. Proficient computer skills and technical writing. Strong interpersonal and communication skills. Preferred Experience in a microbiology laboratory setting. Familiarity with bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. Shift role. Shift patterns are as follows: 2 cycle shift = Monday - Friday, 07:00-15:00 and 14:45 - 22:45 Weekend Shift: Week 1: Mon & Tues 07:00 - 17:00, Friday 07:00 - 17:00, Saturday and Sunday 12 hour shift between 07:00 - 21:00 Week 2 = Wednesday & Thursday 07:00 - 19:00
Process Engineer - reports to the Senior Manager, Process Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging and Labelling facility. The main areas of responsibility are as follows: Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, equipment recipe standardisation troubleshooting and process optimisation. Represent Engineering on the Packaging & Labelling Operations Process Team and support to deliver uninterrupted supply of commercial product. Fulfil system ownership responsibilities for all packaging equipment and associated automation recipes required for packaging operations. Process Engineering system owner representative on key capital projects for area expansion currently being implemented in Packaging across different suites. Provide SME input as part of capital project team on design, qualification, cycle development, and GMP release. Implementation of equipment recipe updates required for artwork updates, SKU launch activities, and technology transfers of new products. Lead and support the investigation and resolution of equipment investigations, ensuring appropriate and effective CAPAs are put in place. Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimisation using tools such as DMAIC, SMED and FMEA. Provide coaching and support to the Packaging Operations and Process Engineering team to build their knowledge. Partner with serialisation SMEs to ensure Packaging is ready to meet changing global requirements. Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables. Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities. Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements. Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence. Ensure adherence to high standards of quality and support of a science and risk-based quality culture. Providing coaching and support to the Operations team to build their knowledge of packaging processes and associated recipes. Ensures that all manufacturing methods and practices are consistent with industry and the companies standards. Maintains professional and technical knowledge by attending workshops, reviewing professional publications, establishing professional networks, and participating in professional societies. Other duties as assigned. Education and Experience BA Degree in Engineering - Process, Chemical, Mechanical, or equivalent discipline Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework Skills: CAPA cGMP Packaging labelling equipment
QC Micro Technician Join our team in a dynamic Microbiology laboratory as a QC Micro Technician. We are looking for an enthusiastic and hard-working individual with strong attention to detail, problem-solving skills, and the ability to work independently or as part of a team. This is an exciting opportunity to contribute to our mission of delivering innovative health solutions. Responsibilities Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities. Perform laboratory testing to determine specification conformance and to support site targets, including but not limited to bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. Maintain an adequate, qualified, and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements. Contribute to effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality related systems. Highlight any discrepancies, deviations, or non-conformance in testing or work practices and support investigations as required. Ensure compliance with GMP and EHS guidelines at all times. Participate in training programs as required. Qualifications Required Minimum of Bachelors Degree or higher in a related Science discipline 1-2 years experience in a GMP laboratory environment Good knowledge of GMP, GLP, and aseptic technique. Proficient computer skills and technical writing. Strong interpersonal and communication skills. Preferred Experience in a microbiology laboratory setting. Familiarity with bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing.
The Global External Operations (GEO) virtual site works directly with contract manufacturing organisations (CMOs) globally to produce products. The GEO site is experiencing significant growth in 2026. The GEO Operations Specialist role will serve as an integral member of the GEO Operations team. This role will specifically support biologics and small molecule drug product processing as well as finished goods packaging. Clinical and commercial products are within the scope of the role. The candidate will directly support the GEO Operations Managers/Process Team Leads who are responsible for ensuring seamless supply of product(s) from the contract manufacturing organizations (CMO). The candidate may also need to work independently on specific activities, e.g. operational readiness execution for new product/processes. The GEO Operations Specialist role will report to the Director of Operations, GEO. KEY RESPONSIBILITIES Execute operational readiness requirements to enable CMOs to produce products. Provide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Product and Packaging operations on targeted/prioritized activities). Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.) Own and manage prioritized change controls and deviations within the Quality Management System (QMS) to effective on time closure and no impact on supply. Consolidation and issuance of key performance metrics per Process Team. Provide back-up support for Process Team Leads where necessary (e.g. holidays) Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings. Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate. Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure). There may be a need for this person to execute operational tasks with a view to eliminating or reducing the number of touchpoints associated with a task. This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises. EXPERIENCE & SKILLS: Minimum requirement of 7 years experience within an Operations and regulated environment. Relevant 3rd level qualification. Required skills needed to accomplish the responsibilities/essential functions include: Will have a good working understanding of the processes/unit operations for biological drug product and/or finished goods packaging. Ability to project manage multiple activities/complex project(s). Technological savviness (e.g. power BI) Will have a working understanding of ERP systems (e.g. SAP) Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals. Experience in lean/six sigma/continuous improvement tools and techniques. Excellent written and verbal communication skills. A high level of initiative and drive, as well as excellent organizational skills, are key role requirements. Ability to work independently. Skills: SAP Power BI change controls deviations
Role Description A fantastic opportunity has arisen for an Associate HR Business Partner. In this role you will provide strategic business partner support to the Carlow site and global support functions. You will have opportunities to support a range of assignments across the Ireland HR Network including but not limited to policy development and Compensation/ Benefits. Primary Responsibilities: Provide Strategic BP support across client groups in driving & realising their people strategy. Support delivery of annual performance and talent processes as well as succession planning; provide coaching and feedback on how to improve individual performance to meet business objectives. Proactively manage employee relations to ensure a highly effective workforce capable of achieving business goals. Industrial Relations; model and champion effective partnership with our unions. Support and coach the business to ensure successful management of issues. Represent the company in dispute resolution. Work collaboratively across site and as part of the Irish HR network to provide support in implementing various projects as required. Develop, implement and update local and country HR policies and support communication of same. Work collaboratively with management to provide advice and guidance on compensation and benefits and assist with salary and bonus administration. Lead critical updates to people managers and SLT at monthly forums. Provide SME knowledge to ensure seamless delivery of T&A function (Kronos) of HR. Provide ad hoc administrative support including compliant management of department purchase orders. Role Functions Experience, Knowledge & Skills 2-3 years experience in an HR role, ideally working in a large multi-national environment. Ability to build partnerships and to work effectively with people at all levels. Highly effective communicator with the ability to influence outcomes at all levels of the business. Ability to project manage multiple projects and initiatives through to successful delivery. Effective at managing multiple stakeholders. Good knowledge of Irish and European employment law framework. High level of independence and initiative while working effectively as part of the team. Strong administration skills. Qualifications & Education Bachelors degree; CIPD qualification or relevant diploma and experience Skills: employment law CIPD Kronos
