A leading client in the pharmaceutical/medical device sector is seeking a&nbsp;Team Lead for their Analytical Laboratory. This role is a fantastic opportunity for an experienced and technically strong individual to take a leadership position within a dynamic and regulated laboratory environment.Key Responsibilities<ul><li>Lead and coordinate day-to-day operations of the analytical lab, ensuring efficient testing schedules and timely product release.</li><li>Provide technical support and guidance, especially in&nbsp;HPLC, UV-Vis, and Dissolution&nbsp;techniques.</li><li>Work extensively with Agilent HPLC systems, Empower, and ChemStation software.</li><li>Oversee the implementation of new testing specifications/methods in line with pharmacopeia and customer needs.</li><li>Manage the Stability Programme, equipment calibration, and documentation in compliance with 21 CFR Part 11.</li><li>Approve analysis results and ensure all lab documentation is current and audit-ready.</li><li>Support internal and external audits, and review investigations and CAPAs.</li><li>Identify training needs and mentor lab staff for skills development and performance improvement.</li><li>Deputise for the Lab Manager as needed and deliver monthly quality reports and metrics.</li></ul>Requirements<ul><li>BSc or MSc&nbsp;in a relevant scientific discipline (or equivalent experience).</li><li>Minimum of&nbsp;5 years&rsquo; experience&nbsp;in a GLP/GMP analytical lab ideally within the&nbsp;pharma or medical device&nbsp;industry.</li><li>Strong technical expertise with&nbsp;HPLC, UV-Vis, Dissolution, and lab software.</li><li>Previous team leadership or supervisory experience is highly desirable.</li><li>Excellent organizational, documentation, and problem-solving skills.</li><li>Proven ability to manage, motivate, and develop a high-performing team.</li><li>Strong computer literacy and willingness to travel for business purposes.</li></ul>Why Apply?This is a rare opportunity to join a forward-thinking and technically advanced team where your leadership and technical skills will make a real impact. If you're looking for a challenging and rewarding next step in your career, we want to hear from you.

Team Lead - Analytical Lab

Role Title: Quality Specialist&nbsp;Location: TipperaryTeam: Quality Systems Team, Drug Substance &amp; Drug Product Facilities, Role Functions (Including but not limited to):Core Quality Systems Responsibilities<ul><li>Ensure timely and effective completion of Quality Systems activities schedules and MMD policies.</li></ul>Subsystem Ownership<ul><li>Own designated subsystems as per site System Ownership list.</li></ul>Quality SME ResponsibilitiesProcess, Cleaning, Water, Equipment<ul><li>Lead and support validation standards for Drug Substance &amp; Drug Product (SDI &amp; OSD) facilities.</li><li>Participate in:</li><ul><li>Process Validation Committee (PVC)</li><li>Water Validation Committee (WVC)</li><li>Cleaning Validation Group (CVG)</li><li>Equipment Qualification Validation Committee (EQVC)</li></ul><li>Approve validation documentation and maintain compliance with MMD standards.</li><li>Ensure validation status is maintained post-changes/modifications.</li><li>Support site/capital projects:</li><ul><li>Define validation requirements.</li><li>Provide technical assistance as part of project teams.</li><li>Develop Validation Summary Reports.</li><li>Contribute to Quality Plans for major projects.</li></ul><li>Monitor industry best practices and trends.</li><li>Act as SAP Quality Process Steward.</li></ul>Change Control<ul><li>Act as principal Quality contact for all change requests affecting processing.</li><li>Perform Quality and change analyst review throughout the change control process.</li><li>Assess material control strategies related to process/analytical changes.</li></ul>Laboratory QA Oversight<ul><li>Approve and support systems for laboratory functions, instrumentation, and GLIMS.</li><li>Review and approve:</li><ul><li>Laboratory incidents/investigations.</li><li>Stability reports (Intermediate and API).</li></ul><li>Serve as Microbiology Point of Contact:</li><ul><li>Liaise with site Microbiologist for issues related to water, utilities, environment, excipients, or product.</li></ul></ul>Quality Agreement Management<ul><li>Maintain inventory of Quality Agreements.</li><li>Ensure agreements are:</li><ul><li>Raised, approved, current, and retrievable.</li><li>Communicated with SD&amp;PM, stakeholders, and external parties.</li></ul></ul>Annual Review Management<ul><li>Manage systems ensuring Annual Reviews (AR/APR/PQR) for products and systems (including automation) are completed on schedule.</li></ul>Documentation Responsibilities<ul><li>Create, review, and approve:</li><ul><li>Site Master File</li><li>Validation Master Plan</li><li>Policies and procedures</li></ul></ul>User Access Reviews<ul><li>Approve designated application user access reviews for compliance with site and MMD policies.</li></ul>Quality Council<ul><li>Manage annual Quality Council schedule.</li><li>Coordinate monthly meetings, agendas, minutes, and follow-ups.</li></ul>Supplier Change Evaluations<ul><li>Review and approve Supplier Change Evaluation (SCE) documentation.</li><li>Approve:</li><ul><li>MDS updates post-SCE.</li><li>Supplier Transparency update requests post-SCE.</li></ul><li>Generate supplier quality/technical agreements as needed.</li></ul>Supplier &amp; Customer Complaints<ul><li>Investigate and review internal/external customer complaints within lead-times.</li><li>Investigate and review supplier complaints as per timelines.</li></ul>Regulatory Support &amp; Filing<ul><li>Maintain site licenses and review documentation.</li><li>Provide support for regulatory product filings and respond to CMC requests.</li></ul>QA Regulatory Data<ul><li>Review documentation for regulatory submission.</li><li>Ensure data accuracy and integrity through timely reviews.</li></ul>Returned Goods<ul><li>Manage segregation and disposition of returned goods.</li></ul>Audit Program<ul><li>Support:</li><ul><li>Internal GMP walk-downs.</li><li>Scheduled audits.</li><li>Hosting of Regulatory Inspections.</li></ul></ul>Special Features<ul><li>Operates as part of a self-directed team.</li><li>Monitors CoE performance metrics.</li><li>Participates in initiatives to improve compliance and quality systems.</li><li>Represents Quality in cross-functional teams.</li><li>Promotes GMP awareness site-wide.</li><li>Builds cross-functional relationships.</li></ul>Experience, Knowledge &amp; SkillsTechnical<ul><li>In-depth knowledge of:</li><ul><li>MMD and site QA policies</li><li>GMP standards</li><li>Validation principles &amp; guidelines</li><li>Global Engineering Standards</li><li>Plant equipment, layout, and unit operations</li><li>Documentation and lab testing requirements</li><li>System Development Life Cycle (SDLC)</li></ul><li>Business acumen and decision-making aligned with key business drivers.</li></ul>&nbsp;Business Skills<ul><li>Demonstrated MMD core values and behaviours.</li><li>Proficiency in:</li><ul><li>MS Word, Excel, Access</li><li>eLogs, File &amp; Email management</li><li>Meetings management</li><li>Technical writing</li><li>Time management</li><li>Analytical problem-solving</li><li>Continuous improvement tools</li><li>Inclusion behaviours</li></ul></ul>Leadership &amp; Soft Skills<ul><li>Strong written and verbal communication.</li><li>Proactive mindset and planning skills.</li><li>Brainstorming and idea generation.</li><li>Customer service orientation.</li><li>Excellent interpersonal and facilitation skills.</li><li>Teamwork and collaboration:</li><ul><li>Listening, integrating perspectives, contributing to team goals.</li></ul></ul>Qualifications &amp; Education<ul><li>Minimum: Degree or Postgraduate qualification in Science, Pharmacy, or Engineering.</li></ul><div><div class="py-5 container"><div class="mx-3 mx-md-0"><div class="styles_description__GuR03 px-3 px-md-0"> Our Vision: To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters.For further information on this role please contact Geraldine Gormally on 0861071395&nbsp;&nbsp;<a href="mailto:/%C2%A0recruit@hero.ie">/&nbsp;recruit@hero.ie</a>Check out all our open jobs on our HERO Recruitment website &ndash;&nbsp;<a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.</div></div></div></div><div><div><div class="styles_root__6iuYk px-3 px-md-0 pt-4 pb-3 py-md-5"><div class="container"><div class="text-md-center mb-3 mb-md-5">&nbsp;</div></div></div></div></div>

Quality Specialist 

Quality Control Specialist III Location:&nbsp;Dunboyne, Co. Meath Overview An exciting opportunity has arisen for a Quality Control Specialist &ndash; Validation and Digital Data Quality (QAV/DDQ) to join a pioneering biopharmaceutical facility in Dunboyne. This role is ideal for an experienced quality assurance professional who thrives in a regulated environment and is passionate about driving operational compliance, digital excellence, and validation integrity. This position plays a pivotal role in maintaining high standards aligned with cGMP and global regulatory requirements, supporting both commercial and clinical operations. Key Responsibilities <ul><li class="" data-start="1051" data-end="1237">Lead Quality Oversight Provides quality assurance oversight across Digital Data Quality and Validation functions, ensuring alignment with cGMP, FDA, HPRA, and EMEA regulations.</li></ul><ul><li class="" data-start="1239" data-end="1437">Compliance and Risk Management Proactively engages in cross-functional teams to resolve compliance issues, perform risk assessments, and ensure timely implementation of corrective actions.</li><li class="" data-start="1439" data-end="1603">Project Involvement Participates in all project phases &ndash; from design through commissioning and qualification &ndash; providing essential QA input and approvals.</li><li class="" data-start="1605" data-end="1783">Documentation and Change Control Reviews and approves Change Controls, CAPAs, SOPs, and deviations, ensuring thorough compliance with internal and regulatory standards.</li><li class="" data-start="1785" data-end="2013">Validation Lifecycle Oversight Manages validation activities, including review and approval of DQ, IQ, OQ, PQ, and PV protocols, with a focus on computerised system validation in accordance with GAMP and site policies.</li><li class="" data-start="2015" data-end="2226">Regulatory and Audit Readiness Evaluates emerging regulatory trends and integrates best practices. Assists in internal audits and supports regulatory inspections, ensuring audit-readiness at all times.</li><li class="" data-start="2228" data-end="2382">Continuous Improvement Champions continuous improvement initiatives across the QA function to drive quality, efficiency, and digital innovation.</li></ul>&nbsp;Qualifications and Education <ul><li class="" data-start="2712" data-end="2825">Minimum of 5 years&rsquo; experience in QA/Validation within a GMP-regulated biopharma or pharmaceutical environment.</li></ul><ul><li class="" data-start="2826" data-end="2946">Expertise in validation of computerised systems and process equipment (bioreactors, chromatography, autoclaves, etc.).</li><li class="" data-start="2947" data-end="3046">Strong understanding of GAMP, quality risk management (QRM), and regulatory inspection processes.</li><li class="" data-start="3047" data-end="3126">Proficient in quality systems such as Veeva Vault, TrackWise, SAP, and KNEAT.</li><li class="" data-start="3127" data-end="3209">Skilled in investigations, problem-solving, and root cause analysis as a QA SME.</li><li class="" data-start="3210" data-end="3314">Capable of delivering insights through Power BI and project management experience is highly desirable. </li></ul>For further information on this role please contact Hannah Talbot&nbsp; Phone:&nbsp;086 107 0950 Email:&nbsp;engineering@hero.ieCheck out all our open jobs on our HERO Recruitment website &ndash;&nbsp;<a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Quality Control Specialist III

Quality Engineer&nbsp;To ensure that products and manufacturing processes comply with all relevant quality, regulatory, and industry standards. This role will support and enhance the Quality Management System (QMS), ensuring adherence to regulations such as FDA, ISO, and other applicable standards. The Quality Engineer will collaborate with cross-functional teams to identify and resolve quality issues, conduct audits, and lead corrective and preventive actions (CAPAs).Key Responsibilities<ul><li>Maintain the Quality Management System (QMS) to ensure compliance with ISO 13485 and other relevant standards, continuously improving QMS documentation and processes.</li><li>Conduct product and process audits to ensure adherence to quality standards, regulatory requirements, and internal procedures, identifying areas for improvement.</li><li>Identify and resolve quality issues, collaborating with production, engineering, and other teams to implement corrective and preventive actions (CAPAs) to improve process efficiency.</li><li>Review and approve documentation such as device history records (DHRs), validation protocols, and change control records, ensuring accuracy and regulatory compliance.</li><li>Lead investigations for non-conformances, performing root cause analysis and implementing corrective actions to drive continuous improvement.</li><li>Conduct risk assessments for new and existing products, supporting risk management strategies in accordance with applicable standards.</li><li>Participate in supplier quality management, ensuring suppliers meet quality standards and conducting audits as needed.</li><li>Provide training and support to production, engineering, and other teams on quality standards, regulatory requirements, and best practices.</li><li>Monitor and report on key quality metrics, updating management on quality performance and areas for improvement.</li><li>Support product development projects, ensuring quality considerations are integrated throughout the product lifecycle.</li><li>Assist in preparation for regulatory inspections and audits, ensuring the company is always prepared for compliance evaluations.</li></ul>Education and Experience:<ul><li>Bachelor's degree in Engineering, Quality Management, or a related field.</li><li>3+ years of experience in a Quality Engineer role within a regulated industry (e.g., medical devices, pharmaceuticals, aerospace).</li><li>Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations.</li><li>Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques.</li><li>Experience in conducting internal and supplier audits.</li><li>Ability to lead and implement corrective and preventive actions (CAPAs).</li><li>Knowledge of risk management principles and methodologies.</li><li>Excellent documentation and communication skills.</li><li>Ability to work effectively in a cross-functional team environment.</li></ul>For more on this contact Johanne at 086 4403725 or choices@hero.ieCheck out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval&nbsp;Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. &nbsp;You have supplied us with your personal data in the process of applying for a position. &nbsp;Our client company may have personnel outside of the EEA who will review you data. &nbsp;We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Quality Engineer

<h3 class="" data-start="432" data-end="454">Quality Engineer II&nbsp; Duration: 12 months&nbsp; Job Summary:</h3>The Quality Specialist is responsible for developing, modifying, and maintaining quality standards and protocols to support the manufacturing of finished and semi-finished products. This role collaborates closely with Engineering and Manufacturing teams to ensure compliance with internal standards, regulatory requirements, and continuous improvement objectives. The ideal candidate will demonstrate strong analytical skills, attention to detail, and experience in quality assurance within a manufacturing environment.<h3 class="" data-start="981" data-end="1012">Key Responsibilities:</h3><ul data-start="1013" data-end="2139"><li class="" data-start="1013" data-end="1081">Provide day-to-day quality support for manufacturing operations.</li><li class="" data-start="1082" data-end="1194">Develop and implement methods and procedures for inspecting, testing, and evaluating products and equipment.</li><li class="" data-start="1195" data-end="1312">Collaborate with Engineering and Manufacturing teams to ensure robust quality systems and standards are in place.</li><li class="" data-start="1313" data-end="1506">Design, author, review, approve, and execute qualification and validation documentation, including cycle development studies, in line with internal quality standards and approval processes.</li><li class="" data-start="1507" data-end="1614">Conduct quality assurance testing and statistical analysis to evaluate process and product performance.</li><li class="" data-start="1615" data-end="1699">Recommend and implement corrective actions to ensure compliance and reliability.</li><li class="" data-start="1700" data-end="1782">Design or specify appropriate inspection and testing equipment and mechanisms.</li><li class="" data-start="1783" data-end="1887">Support documentation practices to ensure full compliance with internal and regulatory requirements.</li><li class="" data-start="1888" data-end="1977">Participate in or lead quality projects and initiatives across functions as required.</li><li class="" data-start="1978" data-end="2059">Utilize MES (Manufacturing Execution System); MES experience is an advantage.</li><li class="" data-start="2060" data-end="2139">May act as a mentor to junior colleagues or provide guidance to team members.</li></ul><h3 class="" data-start="2146" data-end="2184">Qualifications &amp; Experience:</h3><ul data-start="2185" data-end="2713"><li class="" data-start="2185" data-end="2298">University degree (Level 8 NFQ or equivalent) in a relevant scientific, engineering, or technical discipline.</li><li class="" data-start="2299" data-end="2401">Minimum 2 years of professional experience in a Quality, Validation, or Manufacturing environment.</li><li class="" data-start="2402" data-end="2517">Practical knowledge of quality systems, process validation, inspection techniques, and documentation standards.</li><li class="" data-start="2518" data-end="2615">Experience in qualification/validation activities and working in a GMP-compliant environment.</li><li class="" data-start="2616" data-end="2679">Proficiency with statistical analysis tools and techniques.</li><li class="" data-start="2680" data-end="2713">MES experience is advantageous.</li></ul><h3 class="" data-start="2720" data-end="2747">Key Competencies:</h3><ul data-start="2748" data-end="3131"><li class="" data-start="2748" data-end="2798">Strong communication and collaboration skills.</li><li class="" data-start="2799" data-end="2889">Ability to work independently with general supervision on moderately complex projects.</li><li class="" data-start="2890" data-end="2973">Skilled in identifying process improvements and implementing quality solutions.</li><li class="" data-start="2974" data-end="3056">Demonstrated attention to detail and a structured approach to problem-solving.</li><li class="" data-start="3057" data-end="3131">Comfortable working cross-functionally and managing multiple priorities. Our Vision: To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters.For further information on this role please contact Geraldine Gormally on 0861071395&nbsp;&nbsp;<a href="mailto:/%C2%A0recruit@hero.ie">/&nbsp;recruit@hero.ie</a>Check out all our open jobs on our HERO Recruitment website &ndash;&nbsp;<a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.</li></ul>

Quality Engineer II

JOB TITLE: Lab Technician&nbsp;&nbsp; Duration: 11 months&nbsp;Role Description A vacancy for a Lab Technician within the QC Bioanalytical laboratory has opened up. This is a great opportunity for recent Science graduates and those looking to get experience within a GMP laboratory setting.Role FunctionsResponsibilities will include, but not limited, to the following:<ul><li>Sample Management within the QC Bioanalytical Laboratory. This will include management of the samples from receipt through to disposal.</li><li>Aliquoting of in-process, release and stability samples.</li><li>Daily calibration of instruments within the QC Bioanalytical Laboratory e.g. Balances, pH meters etc.</li><li>Maintenance and clean down of equipment within the QC Bioanalytical Laboratory e.g. HPLC&rsquo;s, plate washers, PCR&rsquo;s and BSC&rsquo;s</li><li>General lab housekeeping. This will include waste management, reagent stock checks and maintenance of glassware within the laboratory to support testing.</li><li>Solution preparation required for testing e.g. HPLC Mobile phases, raw materials solutions etc.</li><li>Support MPS activities within the QC Bioanalytical Laboratory.</li><li>Perform periodic reviews of lab systems as required.</li></ul>Experience, Knowledge &amp; Skills<ul><li>Experience preferred but not essential</li><li>Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.</li><li>Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA tests.</li><li>Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.</li><li>Knowledge of cGMP &amp; Laboratory Quality Systems.</li><li>Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.</li></ul>Qualifications &amp; Education<ul><li>Degree Qualification in Science/Chemical Engineering/Biological Engineering</li></ul> Our Vision: To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters.For further information on this role please contact Geraldine Gormally on 0861071395&nbsp;&nbsp;<a href="mailto:/%C2%A0recruit@hero.ie">/&nbsp;recruit@hero.ie</a>Check out all our open jobs on our HERO Recruitment website &ndash;&nbsp;<a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Job Details

Team Lead - Analytical Lab

Team Lead - Analytical Lab

Similar Jobs

Team Lead - Analytical Lab

Quality Specialist

Quality Control Specialist III

Quality Engineer

Quality Engineer II

Lab Technician

Search Jobs

Match my CV