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- ...drive and continuously improve the process to identify relevant enforcement actions of key regulatory agencies including FDA EMA MHRA HPRA for AbbVies collaboration with global CoE leads assess the potential impact on AbbVies quality system and identify appropriate actions....SuggestedLong term contractFull timeTemporary workLocal area
- ...Bachelors or Masters degree in Mechatronics Control Systems Electrical Engineering or a related area ~810 years of experience in FDA/HPRA-regulated pharmaceutical or biotech environments. ~ Proven leadership experience in managing projects and people. ~ Strong technical...SuggestedLong term contractFull time
- ...products ensuring adherence to regulatory requirements relevant specifications and customer needs. Communicating with regulatory agencies (HPRA) regarding Manufacturing Licences GMP inspections and any compounding product quality-related issues. Leading the audit process for...SuggestedFull timeLocal area
- ...knowledge of quality processes and systems is desirable. Demonstrated knowledge and application of industry regulations including FDA HPRA EMEA and other authorities. Keshav #LI-KV1 Required Skills: Education and Experience Third-level degree in a science or...SuggestedContract workWorldwide
- ...CAPA change control deviation management and risk assessments for EU qualitysystem. ~ Ensure compliance with EU GMP ICH guidelines HPRA and EMA regulatory requirements. ~ Provide leadership on quality assurance (QA) and quality management system (QMS) SOPs and quality...SuggestedContract workRemote work
- ...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
- ...considerable experience in QC/QA Management Educated Degree level - Chemistry, Pharmacy or Biological Science Extensive experience of HPRA, MHRA & EU approved manufacturing site experience. Detailed understanding of the Irish Medicines Act, European Quality Directives,...SuggestedLong term contractPermanent employmentContract workTemporary work
- ...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...SuggestedPart time
- ...utilities Supports compliance and maintains audit readiness for Validation. Support and participation in regulatory audits (FDA and HPRA) Provides feedback on systems to promote continuous improvement and enhancement of compliance. Identify opportunities to improve...SuggestedFull time
- ...Validation (CSV) Periodic Validation leading reviews and revalidation of computerized systems to ensure continued compliance with FDA HPRA EU Annex 11 and GxP regulations. All activities must adhere to global standards and regulatory requirements. Key Responsibilities:...SuggestedFull time
- ...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
- ...Qualification · Participates in any investigations that may impact the qualified state of equipment, systems, facilities or utilities Education & Experience: · Science Graduate with minimum 5-year experience in Pharmaceutical Industry accredited by HPRA and FDA...SuggestedFull timeContract workRemote work
- ...systems and define validation requirements Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA. Generation and review of CSV project documentation (User Requirement Specifications, validation protocols, reports etc.)...SuggestedLocal area
Grifols, S.A
Dublin3 days ago - ...execution, commissioning, qualification, and handover, in compliance with site quality systems, cGMP, and applicable regulatory requirements (HPRA/FDA). Responsibilities Deliver investment projects with a focus on utilities and building services, including HVAC heat recovery...SuggestedFor contractors
Tandem Project Management Ltd.
Dublin4 days ago - ...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...Suggested
Allergan
Cork2 days ago - ...understanding of GMP in a regulated environment . Experience preparing for and participating in Regulatory and Customer audits (FDA, HPRA, etc.). Experience in Equipment Validation and Change Control procedures is desirable. Strong ability to manage multiple...Contract workRelocation
Cpl Healthcare
Dublin23 hours ago - ...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
- ...Management On call roster National AIMS Management System Management CORESS management and administration Rigid Scope Management HPRA Medical Device Alerts and Field Safety Notices Management and governance on contract and repair budgets Governance and compliance...Full timeContract workWork at office
- ...manufacturing required. Direct experience of GMP management within a pharma/biopharma company is essential and will include exposure to FDA HPRA or other authorities of similar standing. Excellent accuracy and attention to detail. Good knowledge of relevant computer...Full timeFixed term contract
- ...medical devices by maintaining critical building systems cleanroom environments and controlled atmospheres that meet stringent FDA EMA and HPRA standards. As a key leader within JLL Life Sciences operations team you will drive facility uptime ensure regulatory compliance and...Full timeContract workFor contractors
- ...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 culture...Full time
- ...excellence. Maintain high standards of housekeeping, complete administrative duties, and support audits by ensuring the site meets HPRA and Health & Safety requirements. Monitor and report stock discrepancies, damages, and stock-out situations promptly to support root...Full timeWorking Monday to FridayShift work
- ...aspects of the position. Knowledge of Manufacturing Processes GMPs and other industry applicable regulations including those of FDA HPRA EMEA and other authorities. Advanced degree (MS MBA PhD) preferred. Experience in direct interactions with regulatory agencies during...Full timeFor contractorsFlexible hours
- ...consumable specifications Interface with global tech transfer teams on product introduction projects Ensure compliance with GMP, HPRA/FDA, and EHS requirements Provide on-floor technical support during NPI execution Essential Requirements Degree in Engineering...Fixed term contract
Collins McNicholas Recruitment
Sligo, Co. Sligo2 days ago - ...management and testing to support commercial range expansion and feature enhancement. Compliance & Quality: Ensure alignment to GMP HPRA FDA data integrity and Health & Safety regulations. Champion a safe compliant culture and foster right-first-time execution across engineering...Worldwide
- ...operations targets including OEE where applicable. Provides direct interface as a subject matter expert with QA department to interact with HPRA FDA applicable health authority and internal audits. Develop direct reports by securing appropriate training assigning progressively...Long term contractFull timeFixed term contractFlexible hoursShift workNight shift
- ...GDP Quality Specialist is responsible for ensuring compliance with EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01 and the HPRA Wholesale Distribution Authorisation (WDA). The GDP Quality Specialist will also assist in ensuring compliance to the Manufacturers...Full time
- ...and Deviation process. This will include providing expertise and support to investigations. Contribute and assist with Corporate FDA HPRA and other regulatory agencies during audits. Support to any applicable equipment integration design configuration and testing to...Full time
- ...process issues (including escalation and follow up) to minimize production disruptions. ~ Support and assist with corporate FDA HPRA and other regulatory bodies during company audits. ~ L ead on the 24/7 shift team in the absence of the Manufacturing Manager....Long term contractFull timeShift work
- ...Gemba programs and daily / weekly tiered manufacturing meetings. Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages. Support transition from project to...Full timeContract work
Orion Engineering Services Limited
Dundalk, Co. Louth11 days ago
