Orion Group Life Sciences are currently recruiting a Process Development Scientist on behalf of our Multinational Biotechnology Client based in South Dublin on initial 12-Month contract with huge potential to extend. Shift Details: One week: 07:00 to 15:00 Mon - Thurs, 07:00 to 14:00 Fridays Second week: 14:30 to 22:30 Mon - Thurs, 13:00 to 20:00 Fridays This role will require the candidate to provide Process Development (PD) support primarily to the Forensics and Defect Laboratory. The candidate will establish themselves as an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products. Responsibilities would include the following: Leads / assists forensic investigation and identification of defects arising from drug product manufacture and write up of these investigations to cGMP standards. Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment. Working as part of the PD laboratory team be expected to contribute to upkeep / maintenance of a GMP laboratory environment. Provide process development expertise for commercial drug product particle / defect identification and contribute to the maintenance of local and global particle / defect libraries. The position will report directly to Process Development Senior Scientist. Key Responsibilities: Perform experiments, organise data and analyse results with minimal supervision (in a GMP laboratory environment) to evaluate product impact due to process variables encountered during drug product manufacture. Creation, Management and Maintenance of Inspection defect panels / sets. Execution of Knapp studies and data analysis. Establish experimental design, develop and implement protocols, obtain reproducible and reliable results and communicate data to cross functional groups. Ensuring all aspects of laboratory activity adheres to required policies and procedures, including safety and training. Ensure that the laboratory and site meet the quality requirements of its customers and applicable regulations (FDA, EU & international standards). Participate in cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones. Assist in deviation and exception resolution and root cause analysis. Basic Qualifications: Third level bachelor's degree in science, engineering or a relevant quality discipline with 2 - 4 years' experience in a similar role OR Associate's degree and 5 years of directly related experience. Experience in Working in a Laboratory Environment. Knowledge of cGMPs and other worldwide regulatory requirements. Problem solving ability and excellent oral and written communications skills. Preferred Qualifications: Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, inspection, tech transfer (to commercial DP sites) or validation. Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy). Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting an Analytical Scientist on behalf of our Multinational Biopharmaceutical Client based in Meath on an initial 11-Month contract with potential to extend. The Biologics Analytical Research & Development department is seeking applicants for a Scientist position which is a laboratory-based scientific role tasked with analytical testing of drug substance for release, stability and characterization of biologic products under GMP/GDP and analytical method validations/transfers. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The Scientist will run the daily activities in the Biochem laboratories. Main areas of responsibility include: Execution of analytical method validations and transfers (among different sites, and CROs) and write technical protocols and reports. Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP/GDP. Support equipment maintenance, calibration and qualification work. Preparation of analytical methods, SOPs and other documents as required. Other analytical activities in consultation with the Supervisor. Works in accordance with applicable internal company regulations: safety, health and environmental protection. Train new analysts. Required Education: M.S in analytical chemistry/biochemistry or related field or B.S with a minimum of 3 years of experience in the Pharmaceutical Industry. Required Experience and Skills: Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique. Strong oral and written communication skills. Ability to work in a team environment with cross-functional interactions is essential. GMP working experience. Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers. Execution and review of analytical method validations and transfers (among different sites, and between the company and CROs). Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterization for biologics under GMP/GDP. Cross-train Scientists within the department for new and existing technologies. Ability to organise and establish testing schedules and adhere to deadlines. Support equipment maintenance, calibration and qualification work. Perform periodic review of instrument systems. Generate instrument data in support of SDLC Validation. Initiate, review, and support deviations, CAPAs, and risk assessments, and change records as required. Preparation of analytical methods, SOPs and other documents as required. Preferred experience and skills: Understanding of current manufacturing processes. Author technical protocols and reports as required. Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a QC Planner on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. Days role, onsite. Functions: Create a rolling QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques. The plan includes personnel and equipment assignment, and the expected sample schedule. Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centres - centres production, stability, release, PPQ, contract lab testing all incoming samples, including contract lab testing and adhoc testing as required. Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule. Monitor plan execution - assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans if required. Review mid to long-term site plans - perform scenario planning based on product and process changes, test method changes, compliance commitments, staffing levels, and equipment capability. Summarise potential laboratory bottlenecks and propose resolutions to ensure continued laboratory capability. Monitor and summarise the contract laboratory service-level performance against the agreements and the assigned work. Escalate to contract owner if agreed service level is not achieved. Initiate, manage, and coordinate change controls and deviations for the QC department as required. Facilitate investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs are implemented. Be an advocate for continuous improvement. Drive metrics that appropriately and accurately measure QC performance and take action to mitigate as required. Apply project management concepts and techniques, as they relate to planning and test method execution, to meet established delivery timelines. Qualifications/Education: Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment. Experience in planning and project management. A minimum of 2-3 years' experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations. Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a QC Documentation Coordinator on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. Functions: Be a document system expert for the Quality Control Department; this will include document generation and review and document system work-flow expedition where applicable - examples include Standard Operation Procedures, Work Instruction, Policies, Safety procedures, Annual Product Reviews, electronic logs. Format, write and deliver necessary documentation in line with Merck Global Policies, Procedures and Guidelines, regulatory requirements. Support laboratory administration activities through documentation generation, documentation filing, tracking and auditing. Manage and complete department specific assignments, including periodic review of documents. Support continuous improvement by active participation and engagement with laboratory team for document updates out of investigations and corrective actions. Contribution to Kaizen events and documentation improvement projects as appropriate. Ensure timely completion of all assigned documents to meet site metric requirements. Work collaboratively to drive a safe and compliant culture in Carlow. Participate in QC daily meetings and ensure effective communication of assigned tasks/projects etc. Education/Qualifications Typical Minimum Education: Degree preferred; ideally in a related discipline Typical Minimum Experience: Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting. Technical: Proficiency in Microsoft Word, Office, Excel and electronic data management systems Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Understanding of Lean Six Sigma Methodology preferred Business: Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner Ability to work with teams and escalate issues to management in a proactive manner Customer service Goal/results orientated Training skills Effective time management and multi-tasking skills Proven organizational skills Excellent attention to detail Self-motivated Flexible approach Planning and scheduling skills #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a Scientific Technical Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract. Responsible for generating and expediting review and approval processes for QC GMP documentation including but not limited to Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, Standard Operating Procedures, Standard Work Instructions and change controls, Annual Product Reviews, Trend Reports, Out of Process Control Limit events, Compendial Assessments. Author/Provide technical expertise and technical oversight of the above QC documentation. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers. Key Responsibilities: Support Quality Control activities in the QO laboratory through documentation generation and investigations associated with GMP activities. Author/Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit OOPCL completion. Be a document system expert; this will include document review, approval and document system workflow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls. Support Laboratory activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system. Support Batch release through timely Investigations, Quality Notification, Out of Process Control Limit OOPCL completion, Interim/summary report generation; meeting batch release requirements. Perform Compendial Assessments. Author Annual Product Review, Trend Reports. Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system. Required to comply with 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. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Assist in the management and/or assignment of QC training if required. Qualifications/Education: Bachelor's Degree or higher preferred; ideally in a Science, or other technical discipline. Relevant experience in QC Laboratory within GMP setting. Proficiency in Microsoft Office and job-related computer applications required with proven analytical and systematic problem-solving skills. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Analytical Method validation. Strong influencing skills. Flexible approach. Effective time management and multi-tasking skills. Proven organizational skills. Excellent attention to detail. Trouble shooting skills. Goal/results orientated. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a QC Sample Coordinator on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract. Responsible for supporting the Quality Control Department in the management of laboratory sample handling and various administrative duties associated with sample management. Ensuring that objectives are effectively achieved to, consistent with the requirements to ensure Compliance, safety and reliable supply to our customers. This is a Day role based on site (Mon-Fri). Role Functions: Sample Coordinator will act as point of contact for sample management in the QC Laboratory Responsible for QC sample management from receipt to disposal Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC Laboratory and ability to identify gaps in processes or systems. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) Proficient with Lab management software system (LIMS) Prepare documents and coordinate Sample movement within the Laboratory. Review eLogs and/or LIMS to align physical quantities of samples in freezers/refrigerators. Take ownership of processes related to sample handling e.g. oversight of freezers/refrigerator clean schedule. Perform or support sample management related non-conformance investigations. Supports Internal and Regulatory Audits. Format, write and deliver necessary documentation in line with Merck Global Policies, Procedures and Guidelines, regulatory requirements. Support continuous improvement by active participation and engagement with laboratory team during investigations and subsequent corrective actions. Ensure timely completion of all assigned documents to meet site metric requirements. Work collaboratively to drive a safe and compliant culture in Carlow. Participate in QC daily meetings and ensure effective communication of assigned tasks/projects etc. May be required to perform other duties as assigned. Experience, Knowledge & Skills Technical: Proficiency in Microsoft Office, Excel, and job-related computer applications required i.e. LIMS Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Understanding of Lean Six Sigma Methodology preferred Business: Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team-oriented manner Ability to work with teams and escalate issues to management in a proactive manner. Planning and scheduling skills Customer service Goal/results oriented. Training skills Effective time management and multi-tasking skills Proven organizational skills. Excellent attention to detail Self-motivated Flexible approach Qualifications & Education Typical Minimum Education: Degree preferred, ideally in a related discipline. Typical Minimum Experience: Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting. Our role in supporting diversity and inclusion as an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a Cell Culture Analyst on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract. Responsible for the effectiveness of the Cell Culture laboratory focused on carrying out cell culture techniques, culture handling-maintenance and culturing of cell lines and carrying out cell-based bioassays. Act as a cell culture SME and supporting troubleshooting activities. This is a day role, Mon-Friday based on site. Role Functions: Work as directed by the Quality Control Manager / Associate Director, according to Company safety policies, cGMP and cGLP. Required to drive compliance with the Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Perform routine cell culture maintenance. Responsible for planning and overseeing cell culture activities. Develop, implement and maintain procedures that comply with appropriate regulatory requirements. Ensure that all Quality Systems within the department are adhered to on a daily basis. Operate as part of the QC team performing the allocated testing and laboratory based duties. Participate in laboratory management (equipment, stocks, cleaning). Ensure timely completion of all assigned data processing and reviewing. Ensure timely completion of Laboratory Investigation Reports and deviations through site procedure. Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc. Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved. Where applicable, review, approve and trend test results. Participate in the laboratory aspects of OOS investigations. Ability to lead/mentor team of lab analysts. Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc. Provide support with audit/inspection requirements to ensure department compliance/readiness. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Experience, Knowledge & Skills Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Knowledge of cGMP Cell culture techniques, media preparation, cell thaw and cell based bioassays microscopy. Laboratory Quality Systems. Proficiency in Microsoft Office and job-related computer applications required. Report, standards, policy writing skills required. Understanding of Lean Six Sigma Methodology preferred. Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Planning and scheduling skills. Flexible approach. Proven organizational skills. Effective time management and multi-tasking skills. Excellent attention to detail. Trouble shooting skills. Experience in handling adherent and suspension cell lines. Qualifications & Education Minimum Education: Bachelor's Degree or higher preferred; ideally in a science related discipline. Typical Minimum Experience: 2 years prior related work in handling cell culture and cell culture methodologies preferably in a GMP Setting. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a Project Engineer on behalf of our Multinational Biopharmaceutical Client based in Tipperary on an initial 11-Month contract with potential to extend. Join the dynamic Site Projects Group as a Project Engineer and support site Capital & Expense projects in Ballydine. As the Project Engineer, you will report to the Site Projects Lead and play a crucial role in driving project success within our site portfolio of projects. We are seeking a passionate individual with the experience, dedication, and excellent communication skills to excel in this role. Key Responsibilities: Develop and execute project plans to meet established schedule, cost, and performance standards. Manage design, commissioning, qualification, schedule, and cost in collaboration with project team members, operations personnel, contractors, and suppliers. Track and report project progress against deliverables as required. Work collaboratively to promote a safe and compliant culture on site. Ensure timely and within-budget delivery of projects and assigned duties. Manage multiple capital project executions in parallel, ensuring high-quality results meeting company standards. Oversee site construction activities, particularly during busy periods and annual leave periods. Qualifications and Skills: Engineering qualification, preferably in Chemical, Mechanical, Electrical, or Project Management disciplines. At least 5 years of relevant experience in the Pharmaceutical/Biopharmaceutical industry, with expertise in maintenance, engineering, and project management. Bachelor's degree in engineering. Experience with SAP is preferred, but not essential. Understanding of the project life cycle from concept to qualification, with proven experience in this area. Ability to work independently and as part of a team, with familiarity in engineering project management tools and financial management. Commitment to the highest engineering standards, with strong technical and problem-solving skills. Knowledge, appreciation, and experience of working in a strongly regulated GMP environment. Exceptional interpersonal, communication, presentation, organizational, planning, and negotiation skills. #J-18808-Ljbffr
Orion Group Life Sciences are currently recruiting a Quality Specialist on behalf of our Multinational Biopharmaceutical Client based in Swords, Dublin on an initial 11-Month contract with potential to extend. Job Purpose: The Quality Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements. Primary Responsibilities: Provide direct Quality support to production and support areas. Provides presence on the shop floor to support compliance and data integrity. Review and approve GMP documentation/data for accuracy and completeness. Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors. QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents. Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs. Provides support to internal audits and regulatory inspections. Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans. Qualification and Experience: Bachelor's degree, in a scientific or engineering field. 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function. Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field. Technical writing skills. Lean Six-sigma and problem-solving tools. MES experience desirable Desire to continuously learn, improve and develop. Leadership skills coupled with good oral and written communication skills. Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment. Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment. #J-18808-Ljbffr
Orion Group are currently recruiting an Associate Specialist, Quality Assurance on behalf of our multinational biopharmaceutical client based in Carlow on an initial 11-month contract with potential to extend (2 cycle shift role). Responsible for ensuring that the process for the manufacture of drug product at our Carlow site is in compliance with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with company's requirements to ensure compliance, safety and reliable supply to our customers. For Applicants, it is important to note that this will be a Shift IPT Role. The Shift pattern will be discussed in interview, as patterns of shift will differ at project stages/s. Key Responsibilities: Documentation: Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems. Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same. Support the development and implementation of improved quality reporting measures. Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process. Quality Oversight: Work collaboratively to drive a safe and compliant culture in Carlow. Work shift patterns in line with manufacturing operations to ensure Quality oversight as required. Provide effective real time on the floor support for day-to-day manufacturing operations for example area clearances, batch record reviews, aseptic operations. Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained. Provide training in all aspects of Quality Management Systems and GMP. Ensure all work is carried out in line with SOP's, training or other quality systems such as change controls where applicable. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Drive compliance with company 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. Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete, review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems. Continuous Improvement: Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring IPT is audit/inspection ready. Conduct area inspections for IPT as appropriate. Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same. Such ongoing monitoring/metrics gathering may include: Monitoring of quality systems, The self-inspection program, Verification of the effective implementation of key GMP programs Effectiveness of Preventative Actions Leadership activities including selection, development, coaching, and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs. Required to comply with company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Experience/Education: Third Level Degree qualified in a Science/Technical or related discipline. Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site. GMP Audit experience in the pharmaceutical industry. Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends. Communication, decision making, people influencing, and project management skills will be important. Report, standards, policy writing skills required. Demonstrated ability to make and act on decisions while balancing speed, quality and risk. Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights. #J-18808-Ljbffr
