Sr Quality Systems and Compliance Specialist Dunboyne, Ireland | Posted on 12/16/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years City: Dunboyne State/Province: Meath Country: Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. Employee Value Proposition Employees are the "heartbeat" of PSC Biotech. We provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. The purpose of this role is to work within and support the Global Development Quality Assurance team at the Research & Development Division facility in Dunboyne. This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates. It will also support the interface of SAP with IPI Product structure and MES BOMs and recipes. Other activities to support Quality Systems and QA Operations will be required as per the start-up schedule. The QA Systems and Compliance Team will work closely with the Operations, Engineering, Validation, Supply Chain, and AR&D Functions to ensure compliance with Global and Regulatory Quality Management System requirements as they pertain to the Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management, and associated electronic systems. Accountabilities include but are not limited to the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs, and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and ensure activities are in compliance with the current Quality Manual Requirements. Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management, and Quality Risk Management, per schedule. Support creation, maintenance, and continuous improvement of Quality Management Systems (QMS) and associated documentation. Create and maintain assigned SOPs. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance with GMP and site requirements at the start-up facility. Support site QA Operations and QA Validation colleagues, as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics. Ensure the escalation of compliance risks to management in a timely manner. Additional activities as assigned by the manager/supervisor. Requirements 2-3 years’ experience in an FDA/EMA regulated environment, ideally in Quality Assurance, Quality Control, or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in QMS development and maintenance. Previous experience in QRM, SQM, Deviations, and Change Control, participating in investigations and problem-solving. Strong attention to detail and precision in preparing and reviewing GMP documentation. Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X, etc. or similar. Strong written and verbal communication skills. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals. Bachelor’s degree, or higher, in a Life Science discipline. This role is a hybrid role. #J-18808-Ljbffr

Job Description An amazing opportunity has arisen for a Shift Engineer/Technical Lead . The Shift Engineer/Technical Lead provides technical expertise to the manufacturing shift team in support of drug substance production. Work with the manufacturing shift team to ensure the effective and efficient on-time delivery of batch production. This requires the delivery of process excellence and reliability across all areas of the manufacturing process. This role is site-based and shift-based. What you will do: Support the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, right first-time execution, compliance and team training. Provide technical expertise in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process subject matter expert. Create and sustain a culture of right first time in safety, quality and continuous improvement through a focus on principles of lean including simplification, standard work, visual management and learning development. Ensure highest Quality & Compliance standards. Act as a subject matter expert for troubleshooting process issues during tech transfer activities and commercial operations. Drive a culture of Continuous Improvement by deploying Six Sigma tools within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the process. Coach manufacturing personnel to increase technical knowledge of critical process steps on the floor. Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements. Lead complex process investigations on the production floor in support of deviation resolution. Provide ongoing coaching and support to cross-functional team members, to share manufacturing best practices. Track and trend relevant technical and business process metrics to ensure operations are performing effectively and efficiently. Ensure the effective use of material, equipment and personnel in producing quality products. Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate. Get actively involved by participating in inspections, GEMBA’s and Go-See’s. What skills you will need: General competencies: Excellent communication, decision-making, people influencing and project management skills. Excellent focus and attention to detail. Demonstrated problem-solving capabilities. Ability to work independently and as part of a cross-functional collaborative team to achieve mutual goals. Technical competencies: Thorough knowledge of current Good Manufacturing Practices (cGMP). In-depth working knowledge of manufacturing operations. Ability to read, write and understand technical information. Minimum Education/Experience: Degree in Science, Engineering or other technical discipline. 5 years experience in a large-scale biologics manufacturing facility, including a technical or manufacturing support role. As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today. Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description: DS Manufacturing shift engineering. Search Firm Representatives Please Read Carefully: Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/6/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R318215 #J-18808-Ljbffr

ref. 01246 QA Specialist – Compliance and Quality Systems Exciting opportunity for a QA Specialist to join our client, a leading Pharmaceutical company located in Dunboyne, County Meath. Role This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates in addition to providing support interface of SAP with IPI Product structure and MES BOMs and recipes, among other activities relevant to the position. You will work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the company’s Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems. Responsibilities • Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. • Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. • Support implementation and training for site Quality Systems and ensures activities align with the current Quality Manual Requirements • Create and maintain assigned SOPs. • Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management and Quality Risk Management, per schedule • Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. • Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. • Support site QA Operations and QA Validation colleagues, as required. • Work collaboratively to guarantee strong relationships with management and colleagues and to drive a safe and compliant culture. • Ensure the escalation of compliance risks to management in a timely manner. • Support gathering of site metrics. • Additional activities as assigned by the manager/supervisor Requirements • 2-3 years’ experience in an FDA / EMA regulated environment,ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. • Experience in QMS development and maintenance. • Bachelor’s Degree or higher, in a Life Science discipline. • Proven experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving. • Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar. • Strong attention to detail and precision in preparing and reviewing GMP documentation. • Strong written and verbal communication skills. • Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals. • Ability to work as part of a team and on own initiative in a constructive manner. #J-18808-Ljbffr

Job Description An amazing opportunity has arisen for a Senior Maintenance Engineer at our Dunboyne facility. This position will support manufacturing operations by ensuring safe, compliant and reliable operation of process equipment. The individual will serve as a Subject Matter Expert for defined equipment and maintenance processes. They will help drive continuous improvement related to maintenance and process equipment reliability. What you will do: Support Plant Engineering personnel in the routine maintenance of Manufacturing Equipment. Troubleshoot equipment issues by performing investigations, root-cause analysis and implementing corrective and preventive actions. Work closely with Plant Engineering and Process Engineering technical personnel on equipment maintenance and performance issues. Identify and implement continuous improvement opportunities. Troubleshoot and remediate unplanned downtime on critical site equipment. Lead investigations to ensure robust CAPA’s are identified and implemented. Identify and action areas of operational improvement. Provide guidance to Manufacturing personnel on use of equipment. Drive and Support audit readiness activities. Complete periodic reviews and other compliance documentation aligned with the site Computerized Maintenance Management System (CMMS). Drive and Support site initiatives as required. What skills you will need: 3rd level qualification in Engineering, technical discipline or equivalent. At least 5 years relevant industry experience in biotechnology, pharmaceutical industry or equivalent. Deep investigation skills. Demonstrated continuous improvement mindset. Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture. Good understanding of manufacturing processes, equipment, utilities and maintenance practices. Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution. Employee Status: Regular Job Posting End Date: 01/15/2025 Requisition ID: R325602 #J-18808-Ljbffr

Job Description A fantastic opportunity has arisen for a Senior Finite (Production) Scheduler in Downstream Operations at our Dunboyne site. The Planner/Scheduler will be responsible for efficiently planning and scheduling downstream operations to meet site production requirements while also supporting cadence projects, capacity planning, and analysis. This pivotal role ensures the smooth flow of operations and optimal resource utilisation within the downstream operations team. Tasks and responsibilities include but are not limited to: Function as a core member of the Downstream (DS) Integrated Process Team (IPT) leading all production scheduling activities and planning for the department. Translate master production schedule into dynamic daily plans that ensure seamless operations. Work with the site's other finite schedulers to ensure alignment on Master schedule and communicate downstream operations requirements and potential impacts to department on all scheduling related items. Update the site's Real Time Manufacturing Schedule (RTMS) to build production schedules. Communicate with Operations Leads on RTMS to ensure alignment and adherence to schedule. Facilitate daily operations team meetings and weekly supply review meetings. Communicate the production plan across operations areas, identifying any production or material constraints that may affect progress. Work with operations and planning groups to resolve constraints. Assist in the development of medium-term plans to support scenario analysis, conflict analysis, and production schedule business decisions. Provide planning support to the operations team for all operations planning-related aspects. Provide leadership in DS cadence adherence, ensuring timely analysis/trending of schedule adherence is completed. Work cross-functionally with diverse teams to ensure adherence to plans and foster a culture of continuous improvement. Optimize schedules, address production constraints, and respond to changing demands. Function as the main point of contact for all functional areas to gather critical planning information required for updating and progressing operations plans (e.g., validation, maintenance, engineering, etc.). Generate and present daily, weekly, and monthly reports and metrics, as necessary. Lead, Support Facilitate Continuous Improvement & Problem-Solving initiatives. Your profile Bachelor's degree in Life Sciences, Engineering, Supply Chain Management, or related discipline is preferred. 5 years’ + experience in the pharmaceutical industry (preferably with experience in Drug Substance, Downstream Operations). Lean/Continuous Improvement Qualifications advantageous. Prior experience in planning and scheduling of downstream operations in a biopharmaceutical or pharmaceutical manufacturing environment is highly desirable. Strong knowledge of downstream purification techniques (chromatography, filtration, centrifugation) is advantageous. Familiarity with production planning, scheduling tools, and enterprise resource planning (ERP) systems is preferred. Excellent analytical skills, proficiency in data analysis, and experience with forecasting methodologies. Strong communication and interpersonal skills to effectively coordinate with cross-functional teams, resolve conflicts, and influence decision-making. Detail-oriented and able to manage multiple priorities and deadlines in a fast-paced manufacturing environment. Knowledge of cGMP regulations and compliance in a pharmaceutical or biotechnology setting is advantageous. Proven ability to operate in a highly collaborative manner within a cross-functional organization. Demonstrated flexibility and effectiveness to respond to changing priorities. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today. Current Employees apply HERE Current Contingent Workers apply HERE Employee Status: Regular Job Posting End Date: 01/10/2025 Requisition ID: R326757 #J-18808-Ljbffr

ref. 01244 QA Operations Specialist Fantastic opportunity for a QA Operations Specialist to join our client, a leading Pharmaceutical company located just outside of Dublin. Role The QA Operations Specialist will lead Quality Assurance, being a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. Primary responsibilities involve maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations and provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required. The ideal candidate will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. Responsibilities Lead, facilitate and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the facility. Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility. Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required. Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements. Participate in and support risk management activities in line with relevant guidance and best industry practice. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Ensure the escalation of compliance risks to management in a timely manner. Assist in the execution of the internal audit programme including the performance of audits as required. Work collaboratively to promote strong relationships with management and colleagues while driving a safe and compliant culture. Requirements A Degree qualification (Science/Quality/Technical). 8-10 years of experience, ideally in Quality Assurance, Technical Operations or Quality Control within the Biological and/or pharmaceutical industry. Project Manager capability with strong understanding of Operations. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME. Strong written and verbal communication skills. Experience in quality management systems such as Veeva, SAP, PAS-X etc. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. Strong attention to detail and accuracy in preparing and reviewing GMP documentation. Experience in direct interactions with regulatory authorities during site inspections. #J-18808-Ljbffr

QC Analyst in Analytical Testing - Pharmaceuticals - County Meath - 12-Month Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a QC Analyst. This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely. Main duties will be: Quality Control testing and all associated laboratory activities related to Biochemistry and Analytical Methods. Perform a variety of routine Analytical techniques and associated documentation; including but not limited to Capillary Electrophoresis, UPLC, HPLC, GC, Wet Chemistry methods in compliance with GMP requirements. Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validations. Skills required: Degree qualification (Science/Quality/Technical). 1-3 years’ experience in the biotechnology and/or pharmaceutical industry, particularly in relation to Capillary Electrophoresis, UPLC, HPLC or GC testing. Preferably Lean Six Sigma experience. If this role is of interest to you, please apply now! #J-18808-Ljbffr

CareerMakers Recruitment is currently looking for a General Warehouse Worker for one of our clients based in Dunboyne, A86. Responsibilities: Picking Packing Dispatch Goods in Requirements: Committed and dedicated individuals Flexible and customer-centric approach Previous experience in a similar role Great team player but also able to work alone where required Excellent attention to detail Good communication skills Able to work in a fast-paced environment and meet deadlines and targets. Shift: Monday - Friday, 8am till 5pm. Pay rate: €12.70 per hour If you are interested in the role and have the relevant experience, please apply with your CV or give us a call. #J-18808-Ljbffr

We are hiring a Cabinet Maker / Workshop Assistant . We are a small business specializing in bespoke kitchens and bedrooms, providing the best service to our clients. We hope to find someone who will add to our team and who would like to grow with us in a positive environment. If you are hardworking and passionate about making the best furniture, we want to hear from you! Responsibilities: Work on bespoke kitchen and bedroom projects. Assist in the workshop with various tasks related to cabinet making. Utilize CNC machinery (experience with CNC would be a plus). Qualifications: Experienced cabinet maker or workshop assistant preferred. We will also consider a candidate that might not be qualified but has relevant experience. Salary: €17 - €20 per hour. #J-18808-Ljbffr

Production Scheduler - Dublin, Ireland - 11-Month Contract Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Production Scheduler. This is a fantastic opportunity to be involved with the critical investment projects both on-site and remotely. Key Accountabilities: Creation of the production finite schedule in RTMS by coordinating with the relevant stakeholders, schedulers and planners across the site. Governance of the site finite schedule and tracking of the relevant schedule KPIs to drive continuous improvement. Material allocation of direct materials to support the finite schedule. Work with the Planning and Scheduling Lead, planners and schedulers across the site to ensure success of finite schedule. Work with end-to-end functions, including manufacturing, process engineering, and warehouse, to enable continuous improvement of the underlying capacity assumptions. Coaching and mentoring of Production Scheduler. Educational and Experience Requirements Enterprise mindset to ensure the right priorities are set for the site. Strong project management skills to support schedule delivery. Good stakeholder management skills to manage both internal and external stakeholders that support the site. Good influencing/collaboration skills and teamwork mindset. Excellent troubleshooting and problem-solving skills. Ability to challenge the status quo with a continuous improvement mindset. Effective communicator. Promoting a culture where diversity and inclusion is supported. If this role is of interest to you, please apply now! #J-18808-Ljbffr