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/...SuggestedFull time
- ...exercises judgement to evaluate impact and determines appropriate actions Review and approval of GMP internal Deviation investigations and CAPAs Review and approval of GMP external (supplier) investigations Identifies problems and generates alternatives and recommendations...SuggestedPermanent employmentFull timeFor contractorsLocal area
- ...system is established and executed on site level, that identifies and investigates quality deviations to root cause, defines appropriate CAPAs, ensures CAPA effectiveness and timely reporting in accordance with regulatory requirements. Support direct handling and resolution...SuggestedTemporary workLocal areaWorldwideOffshoreFlexible hoursShift work
- ...Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports. Support facility projects passionate about process development and...SuggestedLocal area
- ...site. Key duties include leading self-inspections, conducting facility walk-throughs, managing the self-inspection program (scheduling, CAPAs, training), supporting regulatory inspection readiness, participating in global audits, and auditing third-party suppliers. This role...SuggestedRemote jobLocal areaWorldwide
- ...Internal Audit program to ensure that all audits assigned are completed in a thorough and timely manner. Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner. Lead with NC/CAPA and planned deviations...SuggestedFull timeFixed term contract
- ...with the Standard and regulatory requirements. Provide support for Good Saves Incident & accident investigations and close out of CAPAs in CURVE Assist in the preparation implementation and review of EHS Procedures and other EHS documents appropriate to the scope of...SuggestedFull timeContract workFor contractorsWorldwideFlexible hours
- ...example Value Stream Mapping and identification of weak elements regulatory surveillance Processes include Deviation Investigations CAPA complaints change control Quality Risk Management Documentation and Records Management Audits and Inspections Supplier Management. Mock...SuggestedPermanent employmentFull timeFixed term contractHybrid workLocal areaRemote workFlexible hoursShift work
- ...at contractor/partner sites that may impact compliance status or require regulatory notifications. Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities. Leading generation of QRT summaries as applicable and...SuggestedOngoing contractFull timeContract workFor contractorsHybrid workRelocation package
- ...performance 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 standards....SuggestedPermanent employmentFull time
- ...experienced in dealing with FDA and/or EMA and CFDA and have a solid understanding of quality system in terms of deviation investigation CAPA and change control. Experience with operating and troubleshooting of benchtop equipment is a distinct advantage. Experience with...SuggestedFull timeContract workWorldwideFlexible hours
- ...product filling. Support and lead investigations affecting safety quality or compliance; ensure timely implementation of effective CAPAs. What you will bring Essential Strong knowledge of sterile manufacturing processes aseptic techniques and contamination control...SuggestedLong term contractFull time
- ...External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion associated CAPAs and NC Quality approval). Participate in Site risk assessments. Execute site and quality driven improvement projects...SuggestedFull time
- ...improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls Deviations/CAPAs SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues as...SuggestedFull timeContract workWorldwideFlexible hours
- ...Demonstrated experience with trending and analysis reporting Demonstrated knowledge of adverse event reporting complaint investigation CAPA and corrective action processes Demonstrated leadership skills Demonstrated process improvement and management skills...SuggestedFull time
- ...executing validation protocols and managing validation documentation ~ Working knowledge of Annex 11 21 CFR Part 11 and GAMP guidelines ~ Experience supporting investigations root cause analysis and CAPAs ~ Strong documentation and cross-functional collaboration skills...Full timeLocal area
- ...product issues in support of sterility media fill environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA. As part of the Site Aseptics Team drives continuous improvement of Aseptic Manufacturing Engineering systems and procedures through...Full timeShift work
- ...education and supervision of team members. Coordinate with QA to ensure GMP compliance mange change controls deviation investigation and CAPA implementation and support client audit and agency inspections. Collaborate with MSAT/PEV and related groups for technology transfer...Full timeContract workWorldwideFlexible hoursShift work
- ...and documentation. Maintain validated operation of utilities and environmental systems. Manage change controls, deviations, and CAPAs related to Facilities activities. Lead larger plant equipment and system upgrade projects, ensuring compliance with GMP and safety...Remote jobFull timeFor contractorsWork at officeWorking Monday to Friday
- ...device history records. Quality Technicians assist in identifying, documenting and investigating non-conformances, Customer complaints, CAPAs and internal/external audit findings. They work with operations and quality team members to perform and document problem-solving...
STERIS Canada Corporation
Westport, Co. Mayo5 days ago - ...manufacturing investigations into process deviations and resolution. Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site. Authoring of technical documents, including protocols, reports and...Contract workLocal area
PE Global (UK)
Dublin1 day ago - ...products and shipments to ensure conformance to customer requirements and supporting QA systems such as Training, Internal Audit, and CAPA. Key Responsibilities Perform final inspection of outgoing shipments and incoming OLED materials, ensuring compliance with customer...Contract work
Universal Display Corporation
Shannon, Co. Clare3 days ago - ...qualification and validation phases. Oversee contractor/vendor activities related to CQV execution. Manage deviations, change controls, and CAPAs arising from CQV execution. Interface with project engineering, quality, manufacturing, and automation teams to drive project...Contract workFor contractors
BioTalent Ltd
Cork2 days ago - ...drive structured investigations into customer complaints and internal non-conformances, ensuring timely root cause analysis and effective CAPA implementation. * Collaborate with cross-functional teams to introduce and validate new equipment, technologies, and processes. *...Contract workBoyle, Co. Roscommon10 days ago
- ...system issues, lead root cause investigations, and implement corrective actions Manage automation change controls, deviations, and CAPAs in line with site quality procedures Maintain system documentation, configuration management, and validation status Support upgrades...Hourly payLong term contractContract workLocal areaWorldwideWork visaFlexible hours
- ...projects Ensure effective operation and continual improvement of the QMS, including document control, calibration, internal audits, and CAPA/NCR processes Oversee product and process risk management in compliance with ISO 14971. Manage supplier approval, qualification,...Permanent employment
- ..., inspections, and regulatory activities Ensure adherence to SOPs, work instructions, validations , and quality systems Drive CAPA investigations related to manufacturing and operational issues Leadership & Team Management Lead, coach, and develop a multidisciplinary...Permanent employmentShift work
- ...in implementing appropriate risk control measures. Support Good Saves, incident, and accident investigations. Manage closure of CAPAs in the CURVE system. Emergency Response & Contractor Management Develop and maintain site Emergency Response Plans aligned to...Full timeContract workFor contractorsFlexible hours
Orion Engineering Services Limited
Galway24 days ago - ...technology refreshes with minimal GMP impact. Prepare for and support internal/external audits (e.g., FDA/EMA, client audits), drive CAPA effectiveness, and ensure sustained inspection readiness. Author and maintain SOPs, user guides, and training materials; deliver...Local areaNight shift
- ...13485). Implement and maintain inspection protocols and process controls. Lead investigations into non-conformances and support CAPA implementation. Champion continuous improvement initiatives within the department. Technical Expertise Troubleshoot complex moulding...Permanent employmentFull timeImmediate startShift work
