Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Welcome to AbbVie! We are a global, oral solid dose company that combines the focus and passion of leading-edge research with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work. We are now recruiting a QA BMR Reviewer to join our diverse QA team in Clonshaugh, Dublin. Are you intrigued ? Do you want to learn more? A snapshot of your key responsibilities as a QA BMR Review Technician would be: Reviews BMRs for completion and accuracy. Reviews CPPs of BMRs to ensure there were no deviations from the filed process. Raise and support the completion of CAPAs, Non-conformances and Change Controls. Review, collate and submit the necessary documentation to support QP release of finished product in accordance with Annex 16. Responsible for the management of the retain system for samples and documents. Provide assistance in departmental and regulatory audits. Has the ability to train a colleague in a particular GMP procedure or related activity. Qualifications A third level qualification in a scientific discipline, preferably a B.Sc./M.Sc. Pharmaceutical experience with good working knowledge of cGMP. Strong knowledge of FDA/EMEA regulatory requirements. Excellent organizational, communication and interpersonal skills. Ability to set and maintain the highest standards. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit this link . US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: this link . #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description At AbbVie, our strength lies in our team of experts who conduct ground-breaking science on a global scale every day. In choosing your career & life path, choose to be extraordinary! AbbVie’s operations in Carrigtohill, Cork is a modern bulk tablet finish facility which manufactures solid and capsule formulations. Innovative new technologies, combined with the depth of expertise within the local workforce, has allowed those based there to develop and deliver products and processes to support AbbVie’s wider global needs. These range from small scale clinical trial supply to large commercial manufacturing. We currently have a development fixed-term contract opportunity for a Maintenance Technician in the Engineering Department in our manufacturing facility at Carrigtwohill, Cork. To maintain equipment as per the maintenance program, troubleshoot and resolve malfunctions, propose equipment solutions, report anomalies, ensure regulatory compliance (FDA, IMB, GMP, Safety, and Environmental legislation), and conduct onsite equipment calibration. By fulfilling these responsibilities, the maintenance technician will contribute to equipment reliability, compliance, and optimal performance within regulatory frameworks. Key Responsibilities: To complete maintenance & calibration tasks through the site CMMS Adhere to CMMS System and SOPs Support Maintenance excellence programme by completing w/os correctly and by adhering to the weekly schedule for planned maintenance. Engage with the Maintenance Excellence programme and support the Maintenance Supervisor and the Reliability Engineer in its deployment. Maintain the plant and equipment in optimum condition, and to accurately complete all documentation and Logbooks in a GMP compliant manner. To assist in the drive for reliability excellence and the deployment of the PdM programme Identify and maintain spare parts and tools, to ensure timely maintenance of plant & equipment. Prepare and update assigned SOPs. Be familiar with and adhere to Engineering department SOPs and those of other departments as relevant. To troubleshoot and resolve equipment malfunction. To take a lead role in maintaining plant electrical power supply and distribution. To take a lead role in maintaining plant PLC control and instrumentation systems. Become familiar with plant electrical supply and distribution. Become familiar with all process and utility equipment. Qualifications Craft Qualification in electrical or mechanical trades 2 - 3 Years’ experience in pharmaceutical industry or equivalent Excellent communication skills. Excellent problem-solving skills. MS Word, Excel, Access, Outlook Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit here . US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more. #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description We are looking for a Warehouse Technician at our Manufacturing site in Cork. In this role, the candidate will execute the sampling of raw and intermediate materials, manage the receipt and storage of raw materials, and shipment of finished products while also managing the sampling booth and warehouse to the highest cGMP standards. Sampling Activities: Preparation of LAF booth for material sampling activities Verification of sampling booth equipment daily Work with QC department on sampling schedule alignment Sampling of raw materials, as per procedures Completion of all sampling tasks in compliance with in-house procedures Routine cleaning of LAF booth/Sampling area to cGMP standards Audit compliance Replenishment of Sampling booth stock Optimise the performance of the Warehouse activities: Master and use the relevant IT Manage the warehouse as follows: Take delivery of raw materials and packaging Ensure paperwork is updated immediately Label everything adequately Check the expiry date of substances and packaging Ensure stock rotation (FIFO principle) Manage material returns from production Prepare finished product for shipment Manage waste flow/disposal Use and maintain warehouse equipment e.g., lift truck, fork lift, etc. Operate to the rules of Quality Assessment: Ensure that all warehouse SOPs are updated to reflect current activities Know and apply the warehouse SOP procedures to the daily tasks of the warehouse management Work to cGMP guidelines Carry out routine maintenance activities for QC systems: Execute stock control on sampling and required consumables including reagents and solvents to ensure there is adequate supply to execute tasks. Complete purchase orders as required and manage materials on receipt Participate in training and development activities to ensure that new technologies are applied and that skill level is developed Meet the Quality and Safety Standards: Ensure sampling activities are executed in line with in-house procedures and in compliance with requirements of cGMP Ensure sampling activities are executed in line with safety requirements and good laboratory practice/GMP Keep work area clean and tidy Participation in investigations into exception events as required Contribute to Safety Contribute to the safety of persons and goods within the warehouse Abide by safety regulations i.e., notify superiors in cases of concern Continuous Improvement of activities and systems within the warehouse: Maintain safety and compliance in each operation Report any dysfunction Pass on useful information to others Keep the workplace clean and tidy at all times Be neatly dressed and behave responsibly Qualifications Leaving Certificate minimum Pharma Manufacturing/cGMP environment/Pharma warehouse/QC Good PC skills English fluent written & oral Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit this link . US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: this link . #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description We are now looking for a Validation Manager to join our team in Ballytivnan in Sligo . As a Validation Manager at AbbVie, you will develop and maintain the AbbVie Biologics Ballytivnan (ABB) validation program, ensuring compliance with AbbVie and external regulatory, quality, and compliance requirements. Your role will actively involve participating in the validation program and general quality assurance activities. Key Responsibilities: Lead a team of validation professionals to fully support all validation activities for the biologics products on site. Coordinate and direct the validation and qualification of ABB equipment, utilities, processes, and software, ensuring compliance with AbbVie policies, FDA, European cGMP, and GAMP standards. Generate, maintain, and execute Project Validation Plans and schedules, as well as validation protocols and final reports to cGMP standards. Provide QA support for validation investigations, implementing corrective actions as required. Create, review, and approve validation and qualification documents, managing validation, exception events, and change control processes. Document all validation activities in compliance with cGMP requirements. Perform cross-training within the team and train new team members. Participate in continuous improvement programs to implement enhancements in manufacturing, quality, safety, and training systems. Coordinate activities to maximize team effectiveness and communicate with peers and management regarding area activities, including elevation of significant events or concerns. Engage in cross-functional teams and cost improvement projects, demonstrating influence and leadership to guide team efforts. Qualifications: Qualification and/or degree in engineering or a scientific discipline. Over 3 years of validation/quality experience in a sterile/aseptic environment, particularly in commissioning and qualification areas. 2+ years of people leadership experience. Minimum of 3 years of experience in a cGMP regulated environment. Extensive knowledge of cGMP and regulatory requirements in the pharmaceutical industry. Strong written and oral communication, presentation, and troubleshooting skills. Effective interpersonal, organizational, and leadership skills, demonstrating the ability to work independently and collaboratively in a team. Why AbbVie? Join AbbVie and contribute to a team dedicated to pioneering scientific research and development. We offer opportunities for professional growth and a collaborative work environment focused on achieving excellence. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit this link . US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more. #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn , and Tik Tok . Job Description We are now hiring for the role of Quality Control (QC) Laboratory Supervisor at our state-of-the-art facility in Clonshaugh, Dublin. In this role, you will lead an experienced QC tech team, ensuring seamless daily operations in our QC laboratory. Your work will be pivotal in liaising with local and global teams to facilitate the successful transfer of products to our site and laboratory. Key Responsibilities: Lead and Develop Teams: Cultivate a supportive environment and set clear expectations to ensure team capability in meeting performance goals. Invest in personal development through coaching, mentoring, and tailored growth plans for career advancement. Oversee Laboratory Operations: Manage daily lab operations, ensuring personnel strictly adhere to regulatory guidelines and execute their duties efficiently. Production Support & Coordination: Actively participate in daily Tier 0 and Tier 1 meetings, aligning laboratory initiatives with production schedules and objectives to achieve quality goals on time. Sample & Data Management: Direct management of samples for analytical testing, ensuring both internal and contract laboratories deliver accurate and timely results in accordance with cGMP standards. Compliance and Process Improvement: Monitor laboratory metrics and drive continuous process improvement initiatives, fostering innovation and efficiency in the laboratory. Training and Method Implementation: Provide or schedule comprehensive training sessions, ensuring all staff maintain requisite skills for safe and compliant operations. Lead the introduction and qualification of new methods in line with regulatory requirements. Qualifications: Minimum 3-5 years of relevant Quality Control experience within the pharmaceutical industry. Proven leadership experience with at least 2 years in a supervisory role or demonstrated mentoring capability. Strong analytical laboratory skills with expertise in troubleshooting and method validation/transfer. Ability to align individuals and teams with broader business objectives and manage performance using metrics. In-depth understanding of pharmaceutical manufacturing operations and regulatory requirements. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #J-18808-Ljbffr
