By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role This is a management position in an ethical Solid Oral Dosage Pharmaceutical Formulation and Finished Product plant. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organizational, supervisory, Technical Writing And Investigation Skills Are Required. How you will contribute Act as the formal contact point with the HRPA, the FDA and other Regulatory Authorities. Promote a culture of Compliance, Right First Time and Continuous Improvement. Implement efficiency improvements in Quality and participate in site projects and initiatives. Management and oversight of site Regulatory Compliance and oversee the Contract Manufacturing Business Quality activities for the site. Inspection Management: Prepare and present the Company for both immediate and routine Regulatory Inspections. In addition, you may be involved in attending or conducting overseas facility inspections. Manage and maintain site self-inspection program. Oversight of Annual Product Quality Reviews. Quality data management in SAP and XFP (MES). Management of customer, supplier and service agreements. Oversight of GMP processes (Pest control, contamination control, facility/utility monitoring/requalification etc.). Oversight of GxP processes (system data integrity, periodic and backup reviews). Support the site Quality Management systems including the Deviation and CAPA Management systems, Change Control system, GMP Training and the Vendor Management program. Oversight of validation lifecycle, including documents and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerized systems in line with current industry regulations and guidelines. Oversight of Quality risk Management program at site. Acting as a designee to the Site Quality Head as required. General Responsibilities Drive and promote the corporate values of Takeda-ism within the workplace. Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Drive and maintain staff development. Drive and Maintain Department KPIs. Drive and support site must win battles. Other duties as required and directed by the Site Quality Head, or other Officer appointed by the Board of Directors. What You Bring To Takeda Degree in Science or other relevant field. QP Qualification desirable but not necessary. At least 3 years’ experience working in a Quality or Engineering Management role in a regulated environment. Experience in audit management (HPRA, FDA, Corporate and Clients). Previous experience in Lean Management is preferable. Good knowledge of Pharmaceutical Production & Packaging processes. Solid Oral Dosage processing experience is highly desirable. Good knowledge of GMP, validation regulations and guidelines is highly desirable. A strong technical understanding of processes, equipment and computer systems is advantageous. Experience in data integrity practices would be an advantage. Qualified Person status is desirable but not essential. What Takeda Can Offer You Great compensation package and performance-based bonus. Employer retirement plan contributions. Employee Stock Purchase Plan. Revenue approved profit share scheme. Employer funded income protection. Employer funded private medical insurance with dependants' cover. Employer life insurance contributions. Electric charging points available at parking locations. Employee Assistance Program. Wellbeing and engagement teams. Takeda Resource Groups. Flexible schedule, e.g., hybrid or shiftwork with shift allowance. Family friendly policies. 26 vacation days plus additional days for service milestones. Educational programs and formal training. Development opportunities. Humanitarian volunteering leave options. Subsidized canteen. Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals. More About Us Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and departments, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites, solidifying our commitment to our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years. How We Will Support You Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process. Locations Bray, Ireland Worker Type Employee Worker Sub-Type Regular Time Type Full time #J-18808-Ljbffr
Job Title: Utility Technician Location: IRL - Grange Castle JOB PURPOSE: The Utility Technician’s primary function is to provide maintenance and technical support function to site utilities at the plant while adhering to all site safety policies and procedures in compliance with regulatory, cGMP and to HPRA and FDA standards. RESPONSIBILITIES: Work with flexibility within the Engineering Department and in co-operation with other Departments. Carry out planned/unplanned maintenance on site utility equipment. Proactively follow up on re-occurring technical issues. Use of the computerized maintenance management system to record in detail maintenance activities on equipment/utilities in compliance with regulatory & cGMP requirements. Execution of preventative and corrective work orders using CMMS (SAP-PM). Daily reporting of maintenance activities at tier meetings, ensuring issues and open items / concerns are communicated in a timely and concise manner. Develop and maintain a good understanding of site utilities including Refrigeration, Compressed Air, Boilers, Chillers, VOC system, Generators, and Solvent tank farms. Promote lean maintenance best practices at all times within a continuous improvement environment (AGILE Program). Assist in developing and improving new and existing maintenance plans that are critical to site utilities and within a cGMP environment. Participate in Safety and Environmental training programmes and initiatives. Adhere to safe working practices as set out by the Safety Statement and other company safety rules. Maintaining compliance with site procedures and policies. Participate fully in any cross-functional training initiatives and support training of others as required. Develop and maintain a strong working relationship with all the departments’ customers on site. Permitting and supervision of external contractors on site, ensuring that they adhere to the site safety rules and regulations. Available to respond to ‘on-call’ and ‘call out’ as per a pre-defined rota, if required. GENERAL RESPONSIBILITIES: Participate fully in any cross functional training initiatives. Drive and promote the corporate values of Takeda-ism within the workplace. Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event. Ensure timely completion of all SOP, reading, training and assessment. Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors. EDUCATIONAL REQUIREMENTS: A suitable qualification in a mechanical discipline is preferred. Alternative backgrounds will be considered based on experience. Minimum of a mechanical apprenticeship with a minimum of 5 years’ experience. RELEVANT EXPERIENCE: A minimum of 3-5 years’ experience in the pharmaceutical industry post qualification is essential. Experience operating and/or maintaining utility systems. Experience managing contractors would be beneficial. SKILLS/COMPETENCIES: Proven track record of high performance & delivering results. The determination and drive to sustain current best practices and the ability to identify develop and implement future best practices. Interest in continuous improvement. Experience in the use of SAP-PM would be an advantage. Proficient in the use of Microsoft Office. Good interpersonal skills. Ability to work well independently and as part of a team. Quality mindset, with a patient focus. #J-18808-Ljbffr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description JOB TITLE QC Laboratory Apprentice REPORTS TO QC Team Leader Job Purpose This brief demands a commitment to the quality effort, i.e., the application of sound practices and good technical skills. PERSONAL QUALITIES The QC Apprentice will be trained to possess the following skills: Demonstrate the ability to operate equipment and instruments effectively and according to standard operating procedures (SOPs). Demonstrate the ability to work effectively in a safe manner within the laboratory. Demonstrate the theoretical knowledge of relevant sciences and technology. Handle materials and equipment correctly paying due regard to safety and environmental protection regulations. Capability to perform basic chemistry techniques to include but not limited to the use of Pipettes, Auto-Titrators, pH, Weighing, Diluting to Volume, Volumetric Calculations, Karl Fischer, Thin Layer Chromatography and Physical Testing. Ability to identify and note equipment (for sampling, testing and control) malfunction if it occurs, and informing the QC Team Leader. Responsibilities Understand the fundamentals of Science. Understand the principles of cGMP. Understand the quality systems that are in place and their importance. Ability to work safely in the laboratory, maintaining excellent housekeeping whilst following appropriate safety, environment and risk management systems. Understanding of basic chemistry and microbiological techniques. Knowledge of pharmacopeias. Understand safe laboratory and safe work practices and methods. Knowledge of methods of receiving and logging samples into a QC laboratory. Knowledge of the variety of methods involved in water testing, raw material, in-process and finished product. Understanding the importance of data integrity, recording results in a timely and accurate manner. Understanding the correct labelling of laboratory reagents and samples. Knowledge of “out of specification” investigations and laboratory investigation processes. Knowledge of the purchase systems of QC consumables and liaising with approved suppliers. Understanding the various steps in the production processes – upstream and downstream. Knowledge of calibrating laboratory equipment as required. Knowledge of reporting processes and current deficiencies in GLP/GMP. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event. Participate fully in any cross functional training initiatives. Drive and promote the corporate values of Takeda-ism within the workplace. Ensure timely completion of all SOP, reading, training and assessment. Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors. Soft Skills Communicate effectively using a full range of skills: speaking, listening, writing, body language, presentation. Work and interact effectively within a team. Good technical writing skills. Work independently and take responsibility for initiating and completing tasks. Understand impact of work on others, especially where related to diversity and equality. Time management and ability to complete work to schedule. Ability to handle change and respond to change management processes. Educational Requirements For entry into year 1 of Level 6 QC Apprenticeship Programme: Pass (Grade O6 or better) in five Leaving Certificate subjects, one of which must be maths and one science related subject. 250 CAO points. Or Relevant FETAC Level 5 or Level 6 Graduate. Current employee with relevant experience and qualifications. Relevant Experience Administration experience desirable with a good understanding of general Administrative Skills. CORE COMPETENCIES/BEHAVIOURS Health, Safety and Environmental awareness. Ability to share knowledge and expertise with others. Engage in teamwork. Complete integrity and compliance programmes. Ability to work independently. Reading comprehension. Problem solving. Critical thinking. Time management. Microsoft Office (Word/Excel). Mathematics and statistics. Continuous professional development. Locations Bray, Ireland Worker Type Employee Worker Sub-Type Apprentice / Trainee (Fixed Term) (Trainee) Time Type Full time #J-18808-Ljbffr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Quality Regulatory Compliance Manager Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Quality Regulatory Compliance Manager. Takeda's presence in Ireland was established in 1997 and our Irish operations have played a role in our global leadership in rare diseases, oncology, and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology. How You Will Contribute Manage all Regulatory Compliance functions and coordination of all activities of the Regulatory Compliance Team of QA Specialists and Quality Executives. Provide site support for Global Regulatory Affairs (GRA), especially with regard to the registration of new products (NDAs, SNDAs), supply of Clinical trials, Product Stability Programmes, and the launch of New Products to markets. Support and liaise with Global Regulatory Affairs (GRA), out-licensed partners, Contract Manufacturing Business (CMB) Quality, and divested parties to support regulatory submissions and renewals. Ensure local compliance with globally and partner-managed regulatory dossiers. Support managing CMB and partnerships for the site. Act as Subject Matter Expert (SME) on TILB change controls and API Site Change controls impacting TILB, for local regulatory compliance evaluations. Prepare TIL Bray variation submissions and communicate with HPRA. Be a formal contact point with the HPRA, the FDA, and other Pharmaceutical Authorities. Present during immediate and routine Regulatory Inspections by the U.S. FDA and the HPRA. Assist in the investigation into non-conformances and conduct regulatory compliance reviews. Help develop the existing Quality Department and personnel to deliver high-quality service in Regulatory Compliance. Represent the Quality Department on teams. Manage, direct, mentor, and motivate subordinate staff. Support GMP-related training. Support the operations of Takeda Ireland to ensure pharmaceutical products meet required standards. Participate in the recruitment and training process for Quality Department personnel. Support Agile site projects. General Responsibilities Participate in any training plans. Promote the corporate values of Takeda-ism within the workplace. Foster a culture of safety awareness and ensure timely completion of all SOP, reading, training, and assessment. Complete other tasks as directed by the relevant Director or Officer appointed by the Board of Directors. What You Bring To Takeda Degree in a science discipline is necessary. Completion or participation in a training program to obtain an educational background that meets the requirements of Article 49 of Directive 2001/83/EC (desirable). Regulatory Affairs Qualification is desirable. Minimum 5 years' experience in the Pharmaceutical Industry. Minimum 3 years of Quality Assurance-related experience. Minimum 2 years of experience in a supervisory role. Project Management & Organizational skills. Investigational and technical writing skills. Demonstrated support and respect for all departments. Promote teamwork by fostering a supportive and inclusive team atmosphere. What Takeda Can Offer You Great compensation package and performance-based bonus. Employer retirement plan contributions. Employee Stock Purchase Plan. Revenue approved profit share scheme. Employer funded income protection. Employer funded private medical insurance with dependants' cover. Employer life insurance contributions. Electric charging points available at parking locations. Employee Assistance Program. Wellbeing and engagement teams. Takeda Resource Groups. Flexible schedule, e.g., hybrid or shift work with shift allowance. Family friendly policies. 26 vacation days plus additional days for service milestones. Educational programs and formal training. Development opportunities. Humanitarian volunteering leave options. Subsidized canteen. Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals. More About Us Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth and rapid change. Over the past two years, Takeda Ireland has invested over €55 million to develop our manufacturing sites, solidifying our commitment to our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as a Top Employer for several consecutive years. How We Will Support You Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to ethnicity, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process. Locations Bray, Ireland Worker Type Employee Worker Sub-Type Fixed Term Time Type Full time #J-18808-Ljbffr
