The Quality Specialist role: Participate as functional expert in the cross functional team that manages production right first time at site. Review and approve batch, cleaning and testing documentation. Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives. Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments. Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes. Ensure changes controls raised are documented, assessed and completed. Prepare Annual Process and System Reviews. Act as lead/team auditor to support the internal GMP walkdown and scheduled audits. Participate in the generation and communication of quality metrics. Creation, review and approval of quality procedures as required. What skills you will need: In order to excel in this role, you will more than likely have: Degree or post-graduate qualification in Science, Pharmacy or equivalent. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise). Knowledge and demonstrated expertise in Lean / Continuous Improvement. Experience and knowledge of GMP Requirements for Electronic /paper free operations. Experience in High potency manufacturing desirable. Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately. Teamwork: Interacts with people effectively. Able and willing to share and receive information. Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed. Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people. Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness. Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self-direction. Skills: SAP CAPA OOS GMP
Equipment Validation Engineer required for a leading Biotech facility in Co. Cork to Lead/Execute/Participate in Equipment and System Validation Lifecycle processes. Initially a 7 month contract. ROLE: Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems. Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks. Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems. Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements . Execute/Participate in change controls and other compliance related tasks e.g. non-conformances. Support regulatory audits Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads. Support, lead or guide others in CQV projects. Requirements: Minimum 5 years' experience in a similar role. Hon. Degree in a Science or Engineering discipline . Experience in a GMP environment essential. Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects. Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory Demonstrated high level of complex problem solving and attention to detail. Demonstrated capability of working and collaborating across multiple functional teams. Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment. Skills: Equipment Engineer Validation Biotech
REQUIREMENTS: Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream. Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ. Coordinate technical deliverables within Drug Substance to support the successful product launch. Provide technical support to the operations teams during commercial manufacturing. Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented. Support Batch Disposition activities by providing SME technical support for comment resolution. Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance. Support continuous process and quality improvements through the deployment of Lean Six Sigma tools. Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos. In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization. REQUIREMENTS: Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience. Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches. Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma Experience in a risk-based approach to manufacturing through use of tools such as FMEA Ability to adapt to changing priorities as project demands change EDUCATION: Bachelor of Engineering or Science Degree in Engineering or Technology related discipline. OTHER SKILLS, ABILITIES & EXPERIENCE: Previous experience in an operations role within vaccine manufacturing preferred. Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable Experience in DS process such cell culture, downstream processes Experience in start-up facility advantageous Demonstrated excellence in planning and organizational skills. Demonstrated skills in communication (oral and written) & in particular technical writing. Skills: C&Q Equipment Qualification CAPA FAT SAT
We are seeking a Mechanical Construction Manager to join our team. The candidate should have significant previous experience of Mechanical Construction Management, in the Pharmaceutical / Bio Pharmaceutical industries. The candidate will be working as part of the onsite projects group delivering multiple discipline projects. Job Role and Responsibilities: Mechanical Construction management for Mechanical Equipment and Piping, installation of Mechanical equipment, vessels, pumps skids etc. Proficient in Stainless, Carbon, Lined and BPE Piping installations. All aspects of Health & Safety on site Construction field co-ordination Coordinate contractor activities to monitor and track work ensuring delivery of the schedule and budget. Participate in Constructability, Planning and Safety reviews. Proficiency with reading and interpreting standard construction documents, drawings, schedules, contracts and proposals. Review and contribute project scope, budget and schedule Ability to manage workload of multiple projects of varying complexity Programming works schedule and monitoring building progress, compliance with regulations and costs Experience: Have a strong mechanical background. Minimum of 10 years experience in Pharma/Biopharma industries Ability to manage workload of multiple projects of varying complexity Proven experience in coordinating mechanical construction works including managing the mechanical construction contractor to ensure all aspects of their delivery meet project goals of safety, quality and schedule Experience with construction, startup, and turnover of facilities systems through commissioning/handover would be an advantage. Candidate must have proficiency in a windows-based environment and software (Word, PowerPoint, project, advanced excel and access) Skills: Turnover Mechanical Equipment Piping Stainless BPE coordinating mechanical construction
Laboratory Systems Specialist required for a Biotech facility in Co. Meath, to support the Testing SDWT/Hub for testing of incoming raw materials, in-process drug substance/drug product, stability samples and environmental monitoring of the controlled manufacturing areas and utilities areas. Initially an 11 month contract. ROLE: The motivation to be an inspiring member of a high performing team. The desire to continuously learn, improve and develop. Be the SME on data management systems for instrument control in the laboratories, this includes but is not limited to GLIMS (Global Labware LIMS Platform), Laboratory Execution Systems (LES), Lonza MODA and Waters Empower. Work within an environment of right first time in everything that we do, through a focus on principles of lean, including simplification, standard work, visual management Build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis, compendial assays). A working understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation. The candidate will have strong problem solving and trouble shooting skills Requirements: Degree qualification in a Technical discipline. At least 2 years' experience in laboratory systems, Labware LIMS experience preferred. Previous experience with configuring, building, maintaining laboratory management systems such as LIMS/ MODA and /or Empower systems and interest in coding/ script. 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. Flexible and self-motivated. Skills: LIMS ELISA Tech Transfer
Associate HR Business Partner required for a leading Biopharma facility in Co. Cork, toprovide strategic business partner support to the site and global support functions . Initially an 11 month contract. Role: There will be opportunities to support a range of assignments across the Ireland HR Network including but not limited to policy development and Compensation/ Benefits. Primary Responsibilities: Provide Strategic BP support across client groups in driving & realising their people strategy. Support delivery of annual performance and talent processes as well as succession planning; provide coaching and feedback on how to improve individual performance to meet business objectives. Proactively manage employee relations to ensure a highly effective workforce capable of achieving business goals. Industrial Relations; model and champion effective partnership with our unions. Support and coach the business to ensure successful management of issues. Lead union partnership with one of our three union groups. Represent the company during dispute resolution processes. Work collaboratively across site and as part of the Irish HR network to provide support in implementing various projects as required. Develop, implement and update local and country HR policies and support communication of same. Work collaboratively with management to provide advice and guidance on compensation and benefits and assist with salary and bonus administration. Lead critical updates to people managers and SLT at monthly forums. Provide SME knowledge to ensure seamless delivery of T&A function (Kronos) of HR. Provide ad hoc administrative support including compliant management of department purchase orders. Requirements: At least 3 years' experience in an HR role, ideally working in a large multi-national environment. Bachelor's degree; CIPD qualification or relevant master's degree. Industrial Relations skills and previous experience partnering directly with union groups is essential. Ability to build partnerships and to work effectively with people at all levels. Highly effective communicator with the ability to influence outcomes at all levels of the business. Ability to project manage multiple projects and initiatives through to successful delivery. Effective at managing multiple stakeholders. Good knowledge of Irish and European employment law framework. High level of independence and initiative while working effectively as part of the team. Strong administration skills. Skills: HR Pharmaceutical CIPD qualification
The Manufacturing Science and Technology (MS&T) Drug Product Technical Operations (DS Tech Ops) organization is seeking a highly motivated individual for a Technology Transfer position. DP Tech Ops is accountable for technology transfers and commercial production of finished Drug Product at our Dundalk site. This person will have the opportunity to participate in all areas of Tech Ops. This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization. Responsibilities include: Work with Internal Partners to achieve business goals. Provide support within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection. Responsible for process ownership, demonstrating technical excellence as the subject matter expert (SME) for drug product processes Responsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events. Responsible for technology transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings. Provide on-site coverage in support of Commercial and / or Technology Transfer Person-In-Plant Activities. Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations and Quality Ensure that Site is inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory. Responsible for participation in creating, sharing, and adopting best practices and business process strategies. Education Minimum Requirement: Bachelors degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field. Required Experience and Skills: Minimum of 3 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance Strong communication in English and teamwork skills Preferred Experience and Skills: Proven expertise in aseptic operations, analytical testing, process development and tech transfer. Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable Experience with lyophilized products advantageous Experience in start-up facility advantageous Demonstrated ability to independently manage projects/work to schedule/deadlines Statistics experience (including Proactive Process Analysis and Continuous Process Verification) Experience in deviation management and/or change control and/or equipment support and/or equipment qualification, and/or project management. Skills: Drug Product Annex 1 GMP Filling
Compliance Automation Engineer required for a leading Biotech facility in Co. Meath, responsible for supporting DMO Compliance activities at the single use multi-product biotech facility. Initially an 11 month contract. Role: Ensure permanent inspection readiness within the DMO team. Support generation/review/approval of CSA deliverables. Providing ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members. Manage deployment of Global SDLC/CSA and IT Security policies and procedures. Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training etc. Ensure highest Quality, EHS & Compliance standards. Active participation in the Tier process and proactively resolving issues. Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives. Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics Completion of AIT Investigations, root-cause analysis and CAPA's Strong project management skills to support project delivery and operational readiness. Requirements: At least 4 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant. Degree qualification (Science, Engineering, Technical). Preference for Lean Six Sigma Green Belt. Desirable to have qualification in Project Management and Computer Validation. Very Strong Collaboration, Compliance and Communication Skills A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments). Experience in PLC/SCADA/DCS systems Skills: Compliance Automation CSV Engineering
Role This position within the QA department provides Quality support and knowledge to activities relating to Quality to meet business priorities. The QA Specialist promotes Quality across cross functional teams, to deliver high quality products, ensuring continuous process improvement. The QA Specialist models the behaviours and understands the principles to drive a culture of continuous improvement building a High-Performance Organisation Key Responsibilities Monitor packaging operations and activities within the QA Group to ensure compliance with GMP, SOPs and company quality standards Perform Acceptable Quality Level Inspections on the Packaging Line to verify that Finished Products and Components meet predefined quality criteria. Performs QA Release of packaging components by reviewing supplier documentation, verifying compliance with specifications, and ensuring components are fit for use in production. Maintain traceability and accurate records for all released materials. Generate and manage Packaging-related paperwork to such as e.g. CCFPs, Barcode Issuance Forms Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs. Maintain an organised archiving system for batch records and GMP documentation. Ensure timely filing and retrieval of records to support audits, inspections and internal reviews Participate in root-cause analysis and drive corrective and preventative actions Assist in investigating customer complaints related to packaging defects or discrepancies. Gather data, analyse findings and support resolution efforts to maintain product quality and patient safety Compile and input data for key team performance metrics and and provide accurate reports to support continuous improvement initiatives Prioritize tasks to ensure the critical tasks are completed on time and meet requirements. Write, review and approve Standard Operating Procedures in accordance with the companies Policies. Plan, coordinate and implement packaging related projects within defined objectives and timelines. Collaborate with cross functional teams to achieve project goals and deliverables. Other duties assigned. Qualifications & Experience Required Degree or 3rd level qualification (Science, Quality). Relevant experience (1yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role. Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels. Strong organizational skills, including ability to follow assignments through to completion. Proficiency in PC skills such as Excel, Word, PowerPoint. Excellent written and verbal communication skills. Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations. Desired Experience in preparing lot release files Experience in execution, documentation and follow-up of in-process inspections for Secondary Packaging processes. Evidence of Continuous Professional Development. ERP Experience Good knowledge of Lean / Continuous Improvement practices and root cause analysis. Behaviours Always focused on the patient and customer needs. Curious with learning agility. Operationally excellent, with attention to detail. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective Skills: ERP Packaging Supplier Documentation SOP FDA
Position Summary: The position will be located at the Little Island site and will be part of the Quality Team. This position is responsible for Quality Risk Management and Quality Systems compliance activities as required by Good Manufacturing Practice (GMP). Main duties and responsibilities: The key elements of the role can be broken down into the following clusters: Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained. Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPAs, and NC Quality approval). Participate in Site risk assessments. Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to, Supplier Qualifications. Reclassification of plant areas. Site Data Integrity Program Manages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams. Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews. Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective. Quality review and approval of quality non-conformance (NC) records. Quality point of contact for attendance at Root Cause Analysis meetings. Initiation and ownership of Quality non-conformance records. Quality assessor, reviewer and approval of quality non-conformance (NC) records. Key Skills and Competencies required: Builds strong productive relationships. Demonstrates ability to work with teams and individuals. Seeks opportunities to grow and develop professionally. Uses best practices to improve business operations. Holds self-accountable for compliant and flawless execution. Takes personal responsibility for decisions that successfully build customer value. Effectively manages and adapts to change. Always demonstrate Integrity and Credo-based actions. Education and Experience: Third level Degree in a science or pharmaceutical discipline. A minimum of 3 to 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry. Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. Skills: Risk Management QRM Site Quality Risk Register SQRR Compliance HPRA FDA
