An amazing opportunity to work in the Quality field as a Quality Assurance Specialist at a leading pharmaceutical company. Responsibilities: Work a 4 shift pattern role Technical knowledge of sterile manufacturing processes Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk Respond quickly to unplanned events, technical issues Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance Support the spot check/walk-through process of the production lines Involved in customer complaint investigation if required POSITION RESPONSIBILITIES Provide Quality support to IPT production teams to ensure cGMP standards are maintained. Understanding of sterile manufacturing operations is preferred. Ability to learn and utilize computerized systems for daily performance of tasks. Ability to prioritize, manage multiple tasks, and meet deadlines. Perform timely reviews on batch documentation ( EBR's ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS Typical Minimum Education Bachelor's Degree or higher preferred in a Science discipline Typical Minimum Experience 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing Experience in SAP, MES, Trackwise desirable Technical Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Knowledge of cGMP and GDP essential Report, standards, policy writing skills required Competent in the use of MES and SAP The position is onsite and remote or hybrid is not applicable for this role, This is a shift position 4 cycle - 12 hours per shift e.g Week 1- long week: Monday Tuesday Days, Friday, Sat, Sun nights Week 2- short week: Wed and Thurs Days, Week 3:Long week: Monday Tuesday nights, Friday, Sat and Sun Days Week 4: short week: Wednesday and Thurs Nights Skills: QA SAP TLNT1_IJ
An amazing opportunity to work in the Quality field as a Quality Assurance Specialist at a leading pharmaceutical company. Responsibilities: Work a 4 shift pattern role Technical knowledge of sterile manufacturing processes Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk Respond quickly to unplanned events, technical issues Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance Support the spot check/walk-through process of the production lines Involved in customer complaint investigation if required POSITION RESPONSIBILITIES Provide Quality support to IPT production teams to ensure cGMP standards are maintained. Understanding of sterile manufacturing operations is preferred. Ability to learn and utilize computerized systems for daily performance of tasks. Ability to prioritize, manage multiple tasks, and meet deadlines. Perform timely reviews on batch documentation ( EBR's ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS Typical Minimum Education Bachelor's Degree or higher preferred in a Science discipline Typical Minimum Experience 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing Experience in SAP, MES, Trackwise desirable Technical Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Knowledge of cGMP and GDP essential Report, standards, policy writing skills required Competent in the use of MES and SAP The position is onsite and remote or hybrid is not applicable for this role, This is a shift position 4 cycle - 12 hours per shift e.g Week 1- long week: Monday Tuesday Days, Friday, Sat, Sun nights Week 2- short week: Wed and Thurs Days, Week 3:Long week: Monday Tuesday nights, Friday, Sat and Sun Days Week 4: short week: Wednesday and Thurs Nights Skills: QA SAP TPBN1_IJ
Research Associate The Research Associate will perform & document scientific experiments in collaboration with cross-functional stakeholders as part of the BCoE or Site strategy, and/or in support of commercial & clinical product portfolio. RESPONSIBILITIES Laboratory /Project work: -Executes defined procedures independently to support BCoE studies and investigation activities with lab scale upstream processes in the multi-product lab. -In addition to quick learning of core scientific techniques, principles and protocols, owns small project portions reliable execution and able to summarizes findings. -Understanding the principles of aseptic operation and experience in working in biosafety cabinets. -Experience in daily operations with microbial cell culture (E. coli), including cell thawing and cell banking, seed train expansion etc. -Experience in fermentation process, including fermenter inoculation, daily monitoring, sampling and in-process analysis utilizing standard bioprocess analytical equipment. -Basic understanding of mammalian cell expansion and it's difference in comparison to microbial operations. -Experience in processing of inclusion bodies is desirable. -Produces accurate, reproducible data entries and maintains laboratory quality through adherence to safety and SOPs and able to troubleshoot common problems with guidance. -Expands technical toolkit by adapting and troubleshooting process steps or assays, applies appropriate methods and interprets basic data trends. -Updates and refines SOP/BPD documentation. -Assists in drafting concise technical summaries. -Understanding of fed-batch and perfusion bioprocesses is desirable. -Experience in depth filtration and ultrafiltration is desirable. -Understanding of downstream purification process is desirable. General: -Execute and complete projects independently. -Generate and review data, makes data analysis. -Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving in accordance with GLP. -Support updates of lab instructions, BPDs, SOPs, templates. -Support maintenance and calibration of lab equipment with accompanying documentation. -Contribute to the evaluation of new equipment. -Be a team player with excellent communication skills. -Play an active role in maintaining and enhancing the safety of the workplace and the laboratories. -Comply with applicable GxP regulations, SOPs, HSE, & other guidelines in the laboratory as applicable. -May be required to work periodically out of normal business hours, including weekends. EDUCATION -Bachelor's degree or higher in Science or Engineering EXPERIENCE -A minimum of 1 year experience in the pharmaceutical industry or equivalent strong laboratory experience. -Working knowledge of pharmaceutical regulatory requirements appropriate to level and understanding of the cGMP manufacturing process for Biologics. Skills: Research pharma TPBN1_IJ
SENIOR QUALITY ASSURANCE SPECIALIST - Initially a 12 month contract Responsible for delivery of quality assurance activities for a leading pharmaceutical facility in Dublin, to ensure new products, facilities, equipment, technologies and other continuous improvements are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements. The QA NPI Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the companys business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Technical services , Engineering and Planning to optimize patient supply. Responsibilities Quality Oversight for new product introduction in Bulk Drug Substance facility. Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and requalifications. Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating manufacturing Facility . Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others. Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures. Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, process validation and cleaning validation documents . Review and Approve TRAs, MSRs, SAP requests related to new products . Provide QA support for supplier qualifications. QA review all analytical facility, equipment and method qualifications and validations. Ensure all Materials are sampled and released as per the approved specifications and procedures . Investigation and approval of deviations generated encountered during qualification/validation testing. Participation in the project change control program and deviations for modifications to new and existing systems. equipment. Provide guidance to project teams on Quality regulations for Validation strategy and approach. Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups. Provide sound QA and Compliance support to manufacturing, engineering, automation, utilities, supply chain, and material movement and laboratories. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Actively support audit readiness activities and regulatory agency and internal audits. Requirements: Third level qualification e.g. B.Sc. in science/pharmacy or equivalent with a minimum of 6-8 years experience in cGMP Quality environment; or equivalent combination of education and experience. A minimum of 6-8 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Excellent accuracy and attention to detail Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities. High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required. Previous QA experience aligned to Technical Services, Engineering/CQV reviews, operational (batch records, procedures), supplier qualification, packaging lines, warehousing (including temperature mapping of, along with fridges and freezers) and QC analytical qualifications/validations and laboratories of particular interest. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written. Skills: QA NPI Specialist Pharmaceutical Quality Assurance TPBN1_IJ
Role Description We're building Gateway: a secure, self-service API platform that enables authorised customers to extract animal health data directly, replacing a manual CSV extraction process. Core infrastructure is in place; we need a Product Manager to drive it from beta to full launch, and develop it further. Role Functions (Functions include, but are not limited to, the following) Own the product roadmap from beta onboarding through to general availability Define and prioritise requirements for API documentation, onboarding flows, and customer experience Coordinate with engineering, security, and business stakeholders Manage beta customer feedback loops and iterate on the product Define success metrics (e.g. adoption, usage monitoring, reduction in manual requests) Establish clear roles & responsibilities for ongoing operations post-launch Experience, Knowledge & Skills Must-Have experience: 3+ years product management experience with API or developer-facing products Comfortable working with technical teams on authentication (e.g. OAuth/Okta), API design, and developer documentation Experience taking a product from beta to general availability Stakeholder management across technical and non-technical teams, within a global distributed company Strong documentation and communication skills Nice-to-have: Experience with data platforms or data-as-a-product models Familiarity with API gateways, usage monitoring, or developer portals Background in animal health, life sciences, or regulated industries Experience defining customer onboarding journeys for technical products Qualifications & Education Proven experience more important than qualifications or education Skills: beta onboarding onboarding flows success metrics developer facing products OAuth/Okta TPBN1_IJ
A fantastic opportunity has come up in Cork as a Packaging Technician to complete the packaging of Finished Produce for onward distribution as part of a wider team. KEY RESPONSIBILITIES Detailed batch record keeping which is accurate, complete, legible and in accordance with cGMP requirements. Identify issues on the line and alert the Packaging Equipment Technician. Provide support to the Packaging Equipment Technician to help resolve issues on the line as required Ensure the Packaging area is Inspection Ready at all times. Participate in Regulatory Inspections Assist with writing, review and revision of packing documentation as necessary (e.g. batch records, standard operation procedure etc) Demonstrate commitment to a high level of safety awareness with the Packaging Operations Team. Proactively support continuous improvement and lead initiatives with the Packaging Suite. Lead and support the investigation and resolutions of process investigations. Maintain an exemplary personal training record. Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and Site Quality Standards. REQUIREMENTS: 1-2 years GMP experience. Experience working with Oracle. Skills: Packaging Oracle gmp TPBN1_IJ
Job Purpose The SAP Master Data Steward will support the introduction of SAP and connecting systems to the Dunboyne site and will be responsible for managing, overseeing and leading initiatives for compliant, accurate and timely COMET (SAP) master data to support the flow of materials across the value stream which is enabled by COMET (SAP). Key Accountabilities Lead and govern the process of Master Data creation and provide solutions for the business when issues are raised through the creation process. Provide Master Data Quality Reports and make sure the local data is kept on a high standard of quality Work in collaboration with different stakeholders and drive decision-making to keep high standards of data quality Lead and assist other work streams with material creation in COMET (SAP). Lead Master Data projects & coordinate with stakeholders to ensure master data milestones are met Develop, monitor & cascade learning for master data management Manage & analyse workflow data requests for compliance, accuracy and completeness Design and drive user acceptance testing (for new SAP introduction, data changes, disaster recovery) Train & advise team members on data standards to ensure all data management processes are adhering to the standards Manage data entry in key systems and oversee the end-to-end data management process Accountable for tracking and achieving master data accuracy targets Act as expert and educate team members, end-users, and business leaders on MDM processes and the master data lifecycle to enable accurate, efficient, and timely quality processes and data Collaborate with data owners across multiple Self Direct Work Teams and Hubs to create new and maintain existing data standards Lead resolution of master data-related issues to ensure no interruption to the value stream. Participate as required in the SAP performance management process using forums such as operation meetings, dashboards and other resources Perform other responsibilities as assigned. Educational and Experience Requirements Degree or 3rd level qualification (Business, Science, Engineering) Advanced degree, diploma or certification in Data or Supply Chain Management preferred 3-5 years of COMET (SAP) Master Data experience in the manufacturing environment, preferably in the pharmaceutical industry Experience in COMET (SAP) deployment and setup of master data business processes. COMET (SAP) Master data experience should include an excellent understanding of Material Master, purchasing, BOM, Routing, Quality etc. Possess analytical skills in data management, interpretation, and reporting Excellent communication & interpersonal skills that enable effective working relationships with internal/external stakeholders Demonstrated leadership behaviours Other Job Requirements This role is based current site hybrid work model and based on the demand/requirement on-site presence minimum 2 days a week. Remote work will be approved where you are not required on-site. Focus on Customers, Including Patients: Focus the entire organization on delivering value for customers, including patients, understanding and meeting their needs. Collaborate: Actively listen and seek to understand differing perspectives; work together to achieve the common goals. Act with Candor and Courage: Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions. Make Rapid, Disciplined Decisions: Make timely decisions at the right level with the right data and support them once made. Drive Results: Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Demonstrate Ethics & Integrity: Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation. Build Talent: Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary. Skills: SAP COMET Supply Chain Material Master TPBN1_IJ
Minimum 8 years of relevant experience in Electrical & Instrumentation engineering within the pharmaceutical or life sciences industry in Ireland or similar regulated sectors In-depth knowledge of E&I systems including: Power distribution MCCs, DBs, UPS systems, Instrumentation for process monitoring and control (pressure, temperature, flow, pH, etc.). Ability to produce, review, and approve detailed engineering documentation: E&I Specifications, SLDs, loop drawings, P&IDs, I/O lists, cable schedules etc Familiarity with relevant standards and regulations: IEC, EN, IS, ATEX, I.S. 10101 Experience supporting project lifecycle phases: design, FAT/SAT, installation, commissioning, and validation. Ability to work independently and proactively within a fast-paced pharmaceutical manufacturing site Site based role. Experience: Degree qualified along with 8 plus years experience in E&I design and construction environments Candidate must have proficiency in a windows-based environment and software (Word, PowerPoint, project, advanced excel and access) Good communication skills essential. Skills: MCC PI&Ds ATEX TPBN1_IJ
Inventory Analyst The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. SUMMARY DESCRIPTION The Inventory Analyst for the site is responsible for ensuring raw materials, drug substance, drug product and packaging components are available and ready to support manufacturing operations. This role provides oversight of inventory accuracy, compliance and readiness across all internal and external storage locations supporting the Manufacturing site. KEY RESPONSIBILITIES: Management and oversight of physical inventories and cycle counts in the Warehouse, including reviewing trends, investigating discrepancies and reporting results to stakeholders. Management and oversight of physical inventories and cycle counts in Manufacturing locations, including reviewing trends, investigating discrepancies and reporting results to stakeholders. Management and oversight of physical inventories and cycle counts in 3PL storage locations, including reviewing trends, investigating discrepancies and reporting results to stakeholders. Oversight of raw materials to ensure they are maintained in the correct stock status in SAP. Delegation and verification of the removal of expired raw materials and expired in-process inventory. Support for reporting key metrics to drive inventory cost savings, including scrap reduction, excess and obsolete inventory, expiry and overall inventory levels. Review of current standard operating procedures to ensure they are fit for purpose, and support updates and revisions as required. Compliance with, authorship of and enforcement of SOX (SarbanesOxley Act) requirements, cGMP documentation, practices and regulations. Support for the development and execution of replenishment strategies for raw materials. Identification and implementation of improvements to purchasing and stock control processes. Support for the review of min/max levels in the Warehouse, considering capacity and demand schedules, and identification of opportunities to transfer stock to 3PL warehouses COMPETENCIES Excellent written and verbal communication skills Ability to interpret, analyze and communicate complex scientific data Advanced understanding of statistical and clinical research concepts Understanding of biotech/pharmaceutical clinical and regulatory processes Strong leadership skills, including ability to lead cross-functional teams Demonstrated ability to work effectively in cross-functional teams. EDUCATION AND EXPERIENCE Bachelor's degree in Supply Chain, Business, Operations or a related discipline preferred. Experience in inventory control, warehouse operations or supply chain within a GMP-regulated environment is strongly preferred. Experience with SAP or similar ERP systems is desirable. Experience working with 3PLs and/or manufacturing inventory processes is an advantage. Strong analytical and organisational skills with excellent attention to detail. Ability to investigate discrepancies and drive corrective actions. Strong communication skills with the ability to collaborate across functions including Manufacturing, Quality, Supply Chain and external partners. Ability to manage multiple priorities in a fast-paced environment. Proficiency in SAP and Microsoft Office tools preferred. Continuous improvement mindset with the ability to identify and implement process enhancements. Understanding of cGMP, SOX and inventory compliance requirements The employee may be required to travel up to 10% of the time which may include weekends. TPBN1_IJ
Role Description We are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers in Sterilisation Autoclaves, SIP of vessels Role Functions (Functions include, but are not limited to, the following) Bring energy, knowledge, innovation to carry out the following: Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process. Design/Author/Review/Approve/Execute Execution/development of change controls. Resolving technical issues encountered during study execution. Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities. Technical input into quality notification by authoring/reviewing/approving investigations. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Support continuous improvement through Lean Six Sigma methodologies. Serve as validation representative for cross functional projects and represent the validation team at global technical forums Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance Supporting regulatory audits and submissions as required. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Experience, Knowledge & Skills What skills you will need: In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. Knowledge of CTU equipment qualification Knowledge of thermal mapping equipment Thermal mapping skills Exception / Deviation Management and Change Control. Demonstratable experience of leading technical related projects. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable Evidence of continuous professional development is desirable. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate. Report, standards, policy writing skills required. Equipment and process validation. Sterile Fill-Finish processes and equipment. Proficiency in Microsoft Office and job-related computer applications required Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Knowledge and experience of the below areas will be considered advantageous Equipment Periodic Validation Equipment Validation Lifecycle Project Management Skills/Qualification Filter Validation & Container Closure Validation Autoclave/SIP Sterilisation Validation Dry Heat Sterilisation Isolator Qualification Vial and Syringe Processing Technologies Temperature Mapping Cleaning Validation Skills: Thermal Mapping Cleaning Validation CTU GMP TPBN1_IJ
