Average salary: €24,461 /yearly
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- ...Category: Professional All Job Posting Locations: Cork Cork Ireland Job Description: Duties & Responsibilities: NC CAPA Quality System Investigation Process: Supply Chain Implementation Support efficient and effective investigation training/...Suggested
- A leading medical device company located in County Cork is seeking a Senior Quality Engineer to contribute to the quality operations team. This position involves overseeing quality-related activities and mentoring team members while ensuring high-quality standards. The ideal...Suggested
Stryker Group
Cork4 days ago - A leading biotechnology company in Dún Laoghaire is looking for a Specialist in Manufacturing to manage quality records and lead investigations. The role requires a deep understanding of Good Manufacturing Practices and experience in quality management systems. Ideal candidates...Suggested
Amgen SA
Dún Laoghaire, Co. Dublin15 hours ago - ...compliance with procedures and standards. Manage and close non-conformances (NCRs) and support related investigations. Assist with CAPA activities, documentation, and verification of actions. Support audit readiness by maintaining accurate manufacturing records....SuggestedPermanent employmentShift workAfternoon shift
- ...Participate and Lead various Lab deviation and investigation process such as OOS OOT and non-conformance including the implementation of CAPAs and change control. Develop training process for QC Separation train and coach Separation Associate Scientists and other QC...SuggestedFull timeContract workWorldwideFlexible hours
- ...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...SuggestedFull timeContract workWorldwide
- ...activities including selection of sites identification of Protocol Deviations and implementation of Corrective and Preventive Actions (CAPAs). Drafts reviews and approves relevant documents including (but not limited to) informed consent site worksheets pharmacy manual...SuggestedFull time
- ...in a GMP-regulated manufacturing setting overseeing lifecycle maintenance and validation. Manage Change Controls Deviations and CAPAs associated with Automation Systems. Maintain robust system documentation configuration control and software versioning. Support...SuggestedFull timeRemote workWorldwide
- ...ISO 14971, MDR and other global regulations. Lead quality support for new product introduction including risk, V&V, process controls, CAPA, and documentation. Develop and maintain process validation (IQ/OQ/PQ), equipment qualification, and test method validation with...SuggestedPermanent employmentContract work
- ...Preventative Maintenance (PPM) Change Control System. Support the equipment breakdown process in finding root cause and identifying correct CAPAs. Purchasing of spare parts and supporting inventory control. Gate Keeping Role to review incoming work requests to ensure data...SuggestedFull timeContract workFor contractorsWorldwide
- ...patient safety. Coordinating performing and approving quality documents and records for the site including nonconformance investigations CAPA plans change controls SOPs validation protocols and reports. Supporting facility projects including process development and quality...SuggestedFull timeLocal area
- ...activities Working in a collaborative manner within cross functional work centre team and contributes to investigations Non-Conformance and CAPA closure. Develop a structured maintenance schedule which will align with the manufacturing schedule to minimise downtime. This...SuggestedLong term contractFull time
- ...enhance product reliability and process capability • Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for production issues. • Perform component-level failure analysis of PCBAs to support production and field returns. • Participate...SuggestedFull time
- ...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...SuggestedPermanent employmentFull time
- ...medical and patient-focused programmes. You will facilitate the roll-out of GxP processes, support self-assessments and audits, manage CAPA, and guide associates in risk and issue management. Your expertise will help maintain excellence in risk and quality management, ensuring...SuggestedHybrid workLocal area
- ...change control processes. Conduct periodic reviews and re-validation activities as required. Support investigations, deviations, CAPAs, and audits relating to computer systems. Provide training and guidance to cross-functional teams on CSV requirements and practices...
Project Delivery Partners
Limericka month ago - ...computerized systems Lead periodic system performance, data integrity, and compliance assessments Review change controls, deviations, and CAPAs for compliant system operation Ensure completion and compliance of all periodic validation deliverables to regulatory and company...Full time
- ...distribution. ~ Maintain and improve the Pharmaceutical Quality System (PQS) in compliance with EU GMP and ICH guidelines. ~ Oversee CAPA change control deviation management and risk assessments for EU qualitysystem. ~ Ensure compliance with EU GMP ICH guidelines HPRA...Contract workRemote work
- ...Netherlands or in Ireland. Key Responsibilities Lead supplier event management to resolve material or processing issues. Manage the CAPA system for incoming materials and monitor supplier performance. Oversee supplier qualification processes to ensure sustainable event...WorldwideShift work
- ...electronic logbooks, and batch genealogy within MES environments Exposure to validation planning, audit preparation, and supporting CAPAs or change controls Characteristics We look for candidates who Work well as part of a team. Have excellent problem...Hourly payLong term contractContract workLocal areaWorldwideFlexible hours
- ...components. Demonstrated a clear strategy for performance improvements at suppliers for production output, improved quality, support CAPA activities and monitored for effectiveness. What we Offer Attractive compensation package that includes competitive pay, as well...
Abbott Laboratories
Clonmel, Co. Tipperary5 days ago - ...regulatory requirements.* Proven leadership and demonstration of process continuous improvement.* Experience with deviation investigations and CAPAs.* Demonstrated ability with project management (principles and techniques), initiating and leading cross-functional teams, and a...Permanent employmentContract work
Amgen Inc. (IR)
Dublin2 days ago - ...expansion/upgrade projects. Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks. Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc. Keep...Contract workWorldwideFlexible hoursShift work
WuXi Biologics Group
Ireland1 day ago - ...in design, verification and process validation processes Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems Prior experience in class III medical products highly preferred Prior experience in a medical...
Life Science Recruitment
Dublin5 days ago - ...global regulations disseminating updates and implementing changes into product files and procedures as necessary. Non-Conformance and CAPA Involvement: Participate in the completion of Non-Conformances and Corrective and Preventive Action (CAPA) activities to resolve...Full timeLocal area
- ...GxP audits and regulatory inspections. KPI monitoring: monitor and analyse quality key performance indicators (KPIs), trends, and CAPAs to ensure operational efficiency and effectiveness. Collaboration: collaborate with cross‑functional teams to align on GMP requirements...Contract workHybrid work2 days week3 days week
BIOMARIN
Carrigaline, Co. Cork4 days ago - ...processes; analyze results, make recommendations, and develop reports Analyze and resolve basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Develop training and documentation materials (e.g., work instructions) for production to...Immediate startMonday to ThursdayShift workAfternoon shift
Edwards Lifesciences
Limerick3 days ago - ...quality and compliance issues which may include: Investigate PRAs and complaints for manufacturing related issues Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyse...
Edwards Lifesciences
Limerick2 days ago - ...safety, quality, and compliance. Plan and execute qualifications, oversee FAT/SAT and commissioning activities, and manage deviations/CAPAs. Partner with Engineering, Operations, QA, and IT teams to troubleshoot and resolve issues. Documentation and Procedure Support...Full timeTemporary workWorldwide
CAI
Dublin4 days ago - ...improvement activities. . - Oversee manufacturing related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations. Disposition non-conforming material and work with manufacturer and suppliers to implement corrective and...Long term contract
Life Science Recruitment
Galway4 days ago
