Quality Assurance Specialist, Systems About Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity: Based in our Kerry Plant and reporting to the QA Systems Co-Ordinator, you as the Quality Assurance Specialist will be responsible for supporting compliance with cGMP regulations, as well as the development and maintenance of the Quality Management System. The position is therefore responsible for assisting with the ongoing development, implementation, and maintenance of cGMP compliance. Hybrid Working: At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. Key Responsibilities: Promote cGMP & Quality awareness across all levels of management and staff, ensuring site-wide compliance. Support inspection readiness by ensuring timely, compliant progression of eQMS records. Provide real-time support for manufacturing, QC, and operations, including non-conformance management, root cause investigations, CAPA, and risk assessments. Assist with internal/external audits, regulatory inspections, and the customer complaints process. Review and QA approve SOPs and controlled documents for cGMP compliance across QA, plant, warehouse, and QC. Support supplier qualification, product quality reviews, major projects, and other quality-related activities, including training, investigations, and batch representative on major projects within AICL (KP), including LEAN/ OPEX activities. Other support areas include but are not limited to: quality investigations, TrackWise, ADMS authoring, training of new personnel and batch review activity, as assigned. Preferred Knowledge & Experience: Knowledge of regulatory requirements related to pharmaceutical manufacture. Exceptional attention to detail and organisational skills. Proficiency in Microsoft Office Suite, including MS Excel. Excellent communication and collaboration skills. Prior experience of working in a GMP environment. Education: Third level qualification in Science / Engineering discipline or equivalent. Additional information: This is a 6-month fixed-term contract. Position is based in Killorglin, Co. Kerry. This position requires you to be onsite a minimum of 3 days a week. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Ireland #LI-Hybrid 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.
Systems Engineer About Astellas At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. The opportunity The role of the Systems Engineer will work within a systems team helping to design and implement the automation systems for the site and will oversee the day-to-day operations of autonomous systems, responsible for plant readiness, operation, maintenance, and optimization. Responsibilities: Design and integrate Process Control Systems (DCS, PLC/SCADA) and vendor-packaged equipment to meet business and process requirements, ensuring integration with upstream/downstream systems (e.g., Filling Line, Utilities, MES). Coordinate design teams and automation vendors to implement site automation systems successfully. Create, review, and approve automation/OT project deliverables such as schedules, user requirements, design documents, and IQ/OQ/FAT protocols for various systems. Support qualification and validation activities for automation systems. Develop and maintain site procedures for system administration and maintenance. Configure network parameters, test system communication, document server/network requirements, and troubleshoot/optimize plant automation systems. Essential Knowledge & Experience: Proficient in CQV, full SDLC, and troubleshooting PLC/DCS controllers, I/O faults, and system integration (L2-L3). Experienced in designing and implementing DCS, PLC/SCADA platforms, and OT networks (design, configuration, testing). Strong knowledge of ISA-95, ISA-88 standards, and OT system integration best practices. Education: Third level qualification in Information Systems, engineering, or other relevant Technical/Engineering discipline. Additional information: 20% travel (domestic and International) This is a permanent full-time position Position is based in Tralee - Ireland This position requires you to be 100% on site / in the office We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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.
Head, Clinical Data Enablement, Data Aggregation About Astellas At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. The Opportunity The Clinical Data Enablement (CDE) Head of Data Aggregation will lead a globally distributed team focused on establishing the data flow from source vendors to Astellas for Phase I-IV clinical trials executed by Astellas. This includes transforming data for data review and cleaning purposes while also ensuring that these data are able to be shared to internal Astellas consumers following an established dataflow. Data review and data cleaning are outside the scope of this role. As Head of Data Aggregation, you will play a key role in ensuring that the clinical results data collected in Astellas clinical trials are available for data cleaning and review which is precursor to submitting data to regulatory bodies and/or providing responses to regulatory questions. This role reports to Head, Clinical Data Enablement, Data Science Clinical Data & Information Strategy. This position is based in the UK or Republic of Ireland. Hybrid Working At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver. Candidates interested in remote work are encouraged to apply. Key Responsibilities: Acting as the primary contact and subject matter expert for the Data Aggregation team responsible for resource planning, workload assignment (allocation and prioritization), issue resolution and related escalations to the Data Science Lead Team (DS LT). Defining and leveraging metrics to enable a culture of continuous learning and improvement to optimize the clinical data flow and the availability of clinical results data for decision making. Shares these metrics and related innovations with the DS LT and drives strategic initiatives in this area. Leading engagement with vendors providing source data (i.e. vendors providing lab results, ECGs, biomarkers, etc) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately. Contributing to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within department and across Astellas broadly Ensuring cross functional collaboration with areas performing data management, clinical operations, etc. to address any issues with the delivery or stability of the clinical data flow as appropriate Essential Knowledge & Experience Extensive experience in pharma or the CRO industry working on global clinical studies and projects or global process and system initiatives Effective communication and ability to build strong relationships with vendors and internal stakeholders, lead negotiations to achieve the best outcomes for Astellas for service or data delivery support and issue resolution Significant experience working on systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning Demonstrable leadership and collaboration across geographies and cultures Solid understanding of all phases of clinical development Preferred Experience: Prior experience with people management responsibilities Experience using at least one programming language (i.e. R, Python, SAS, SQL, etc) Demonstrated ability and experience in leading global process or system improvement projects Knowledge of data standards in industry (CDISC, CDASH) Education/Qualifications BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline or equivalent. Additional Information This is a permanent full-time position. This position is based in UK or Republic of Ireland. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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.
