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- ...validation plans, protocols, reports & amendments of the Quality Management System ensuring compliance with the latest Regulatory Agency (HPRA, FDA) directives / requirements within the Medical Device and Pharma Sector. • Generate applicable quality documentation in...SuggestedFull time
- ..., and where relevant, Seveso III • Prepare investigation reports, gap analysis outputs, and audit-ready documentation suitable for HPRA or equivalent regulatory scrutiny • Deliver chemical safety awareness and regulatory briefings to site personnel and management...Suggested
- ...functional team and to manage complexity and change. • Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-...SuggestedHourly payContract workFor contractorsHybrid work
- ...closely with · Pharmacist Executive Manager 3, CUH · Chief Pharmacist CUMH · Clinical Lead Consultant AHR Centre, Cork · Designated HPRA Responsible Person · Multidisciplinary clinical team AHR Centre, Cork · AHR Chief Assistant Technical Services Officer · National...SuggestedPermanent employmentFull timeInterim roleLocal area
- ...Overview Complete Laboratory Solutions (CLS) is Ireland’s highest-accredited contract laboratory, licensed by both the HPRA and the FDA. An Irish-led multinational, CLS provides trusted expertise and solutions to clients across diverse sectors. CLS became part of the...SuggestedContract workWorldwide
- ...Qualification in a relevant science or engineering discipline Minimum 3 years’ experience in batch processing operations within an FDA/HPRA regulated pharmaceutical environment. Detailed knowledge of cGMP and regulatory requirements. At least 3 years’ experience in a...SuggestedFull timeFlexible hoursShift work
- ...Monitoring quality performance and advising management personnel on major quality issues. Liaison with AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies. Regulatory review. Initiation and Completion of Quality related investigations and verification of the...SuggestedFull time
- ...execute all drug product manufacturing operations, ensuring compliance with internal and external regulatory standards (including cGMP, HPRA/FDA). Provide leadership, direction, and motivation to a team of 8-45, ensuring effective performance, strong communication, and...SuggestedFull timeShift work
- ...leads cross-functional initiatives in the Eye Care Business Unit, focusing on delivering projects that align with cost, compliance (FDA, HPRA, EPA), safety, and customer requirements. This role will be key in driving measurable improvements and delivering business unit...SuggestedFixed term contract
- ...methods, equipment, records, and data to ensure alignment with internal standards and external requirements, including cGMP, GLP, ICH, FDA/HPRA, and EHS. Author, update, and maintain SOPs, protocols, and technical records to support audit readiness and regulatory compliance....SuggestedFull time
- ...Monitor and control the manufacturing environment for cleanliness and compliance. Support inspections by regulatory agencies such as HPRA and FDA. Train team members on procedures to meet quality and operational standards. Identify and resolve issues related to...SuggestedPermanent employment
- ...Job/Technical Skills · A minimum of 5 years experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry. Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this...SuggestedFull timeShift work
- ...that all products manufactured at Sligo Manorhamilton Road meet the requirements of end users, regulatory authorities (including FDA and HPRA), and company standards. The Senior Product QA Manager is responsible for compliance with marketing authorisations, current Good...SuggestedFull time
- ...desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Excellent accuracy and attention to detail What you'll get in return What you...SuggestedContract work
- ...analysis and CAPAs in the investigation and resolution of deviations. Project Management skills Demonstrates good knowledge of EU and HPRA GDP/GMP regulations Demonstrates good knowledge of the MDD and MDR for Medical Devices Experience in using an ERP system such as...SuggestedFixed term contractHybrid workRemote work2 days week
- ...12-14 people in total across the broader team. Background in API and Drug Product; biologics would be a plus Experience in FDA / HPRA / GMP-regulated environments Strong knowledge of quality systems, validation, site metrics, SAP/LIMS changes, and data trending QC...Permanent employmentWorldwide
- ...analysis of quality dossiers for licensing, including experience in reviewing and quality check of CMC documents for electronic submission to HPRA Submission of type II safety variations to update SmPC and labelling in line with Company Core Data Sheets Working with PV on...Local area
- ...Involvement in any decision to quarantine or dispose of returned, rejected, recalled or falsified products. Notify and consult with the HPRA on potential recalls or critical quality issues which may impact patient safety. Ensuring that any additional requirements imposed...Contract workHybrid workLocal areaRemote work2 days week
- ...experience within the pharmaceutical industry ~1–2 years’ experience in a team lead or supervisory role ~ Experience working in an HPRA/FDA regulated environment is essential ~ Level 8 degree in Microbiology or a related discipline What We Offer Opportunity to...Contract workFlexible hours
- ...Science or related field Experience Level = 1+ Years Experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines Proven track record in an analytical role. Proficient in using analytical equipment in a QC lab as well as troubleshooting...Contract workTemporary workShift work
- ...of Medicines to the HSE. Responding to regulatory authorities, conformity assessment bodies, and governmental authorities including HPRA, HIQA, Department of Health and the HSE in respect of adverse findings on inspection, audit and in respect of reviews, inquiries and investigations...Full timeTraineeshipHybrid work
- ...you Advanced scientific or medical degree (PhD, PharmD, MD or equivalent) & final signatory Operating fully within ABPI, IPHA and HPRA requirements Strong understanding of the Irish healthcare system, reimbursement landscape, and patient pathways Proven experience...Hybrid workLocal areaRemote work
- ...Surveillance: Design and implement PMS plans, periodic safety update reports (PSURs), and vigilance reporting systems per MDR requirements. HPRA & Competent Authority Liaison: Manage all interactions with the Irish Health Products Regulatory Authority, including device...Permanent employmentFull timeContract workHybrid work
- ...performance of all aspects, of operations and operations personnel within the Manufacturing Department to ensure that, compliance – FDA, HPRA, EPA, Safety, and customer requirements are met. You will provide s.upport to the Manufacturing Technicians IV and Manufacturing...Full timeShift workDay shift
- ...knowledge of GMP and regulatory requirements relating to the pharma/biologics industry. ~1 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable. ~ Requires annual visual test certification for colour blindness and 20/20 vision (essential)...Contract work
- ...Ensure compliance with national, international and professional standards, accreditation requirements and regulatory frameworks (including HPRA, HIQA and other applicable standards). Develop, maintain and control departmental policies, procedures, protocols, PPPGs, SOPs and...Permanent employmentFull timeFor contractorsWork at officeLocal area