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- ...procedures are established and consistently maintained in accordance with GDP standards, aligned with the requirements of the current EU and HPRA regulations. This is a Monday to Friday role. WHAT ARE YOU GOING TO DO? Manage the daily interfaces with supply chain,...SuggestedFull timeContract workWorking Monday to Friday
- ...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
- ...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
- ...Maternity Model of Care, participating as required in relevant national fora and professional networks. · To support the implementation of HPRA VPA guidance and Pregnancy Awareness / PREVENT Programme. · To provide structured and clinical supervision and mentorship to...SuggestedPermanent employmentFull timeContract workWork at officeRotating shift
- ...Proven instrumentation/troubleshooting ability. ~ Good knowledge of procedures, policies and guidelines required to comply with cGMP and HPRA/FDA guidelines. ~ Must be flexible and support the business through working shift and adhering to the standby schedule....SuggestedFull timeFlexible hoursShift workDay shift
- ...seek process improvements. Support quality aspects of MVI, AQL, and NPI process/material handovers. Maintain compliance with cGMP, HPRA/FDA, EHS, and AbbVie standards. Qualifications Third-level degree in science, quality, or engineering. Minimum 3 years’...SuggestedFull timeShift work
- ...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...SuggestedContract workHybrid workLocal areaRemote work2 days week
- ...knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines. Experience in industry is desirable. Additional Information AbbVie is an equal opportunity employer and is committed...SuggestedFull time
- ...preparing and reviewing GMP documentation. ~ Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. ~ Experience in direct interactions with regulatory agencies...SuggestedFull timeContract workWorldwideFlexible hoursShift work
- ...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
- ...management, patient education and nurse led counselling. · Maintaining data, KPIs and participating in audits, JACIE standards and HPRA compliance. · Educating patients, donors and families. · Mentoring nursing staff and support multidisciplinary team...SuggestedFull time
- ...Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Licence awarded by the Health Products Regulatory Authority (HPRA). The Qualified Person (QP) is primarily responsible for release of Nutrition, Chemo and Antibiotic products. They should oversight and...SuggestedLocal areaFlexible hours
- ...Global Engineering and participate in engineering forums. Ensure compliance with procedures, policies, and regulatory standards (GMP, HPRA/FDA). Collaborate with cross-functional teams on projects and improvement initiatives. Champion EHS practices and supports a...SuggestedFull time
- ...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
- ...marketing strategies for Reckitt’s healthcare portfolio across Ireland. Ensure brand messaging is commercially impactful, compliant with HPRA/IPHA codes, and tailored to healthcare professionals (HCPs), pharmacists, and patients. Drive omni-channel engagement and digital...SuggestedLocal area
- ...within life sciences e.g pharma, biotech or medical device. Strong communication and decision-making skills. Strong knowledge of GMP, HPRA, FDA regulatory requirements and current Health and Safety Regulations legislation Ability to work independently and as part of a...Permanent employmentShift workNight shift
- ...of manufacturing areas and drive continuous improvement. Act as SME for quality issues during shift operations. Uphold all cGMP, HPRA/FDA, and EHS standards. Qualifications Third-level degree in science, quality, or engineering. Minimum 3 years' experience in...Full timeShift work
- ...Manufacturing. ~5+ years of experience in a medical device or pharmaceutical manufacturing setting. ~ Strong understanding of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation. ~ Familiarity with industry regulations and safety...Permanent employment
- ...functional team and to manage complexity and change. Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. People are our business worldwide Orion Group was founded in 1987 and is now one of the...Full timeContract workFor contractorsWork at officeWorldwide
Orion Engineering Services Limited
Cork26 days ago - ...guidance and support on quality and compliance matters. Act as a site contact for regulatory and customer audits/inspections (FDA, HPRA, etc.) and prepare site teams for successful outcomes. Manage CAPA (Corrective and Preventive Action) implementation, and follow-up...Full time
- ...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-...Hourly payContract workFor contractorsHybrid work
- ...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...Contract 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...Full timeFlexible hoursShift work
- ...and approval of key documentation (SOPs, protocols, CAPAs, etc.). Ensure compliance and inspection readiness for regulatory agencies (HPRA/FDA) and internal standards. Analyse quality data and metrics to support continuous improvement. Leading strategic global and...Full time
- ...process. Ensure strict adherence to regulatory and customer requirements. Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues. Develop and maintain an internal...Odd jobWork at officeWorldwide1 day week
- ...Ensure every radiopharmaceutical product batch manufactured by Alliance Medical Ireland is tested and certified in compliance with GMP and HPRA guidelines before release to market. Responsible for managing a small team, with early routine production times. This role offers a...Permanent employmentFull timeContract workFor contractors
- ...The QA Compliance Specialist is responsible for maintaining and improving the site quality system to ensure full compliance with GMP, HPRA/FDA and AbbVie quality requirements. The role includes assessing the effectiveness of the quality system and reporting outcomes to senior...Part time
