...accounted for in alignment with plant operations plans.
• Participate in cross-functional project teams as applicable; Implement process CAPA’s and performance improvements, conduct investigation trending.
• Ensure investigations are closed on time, recurring deviations are...
Asset Recruitment
Leinster
2 days ago
...for clean utility systems.
Planning material and spare part inventory for clean utility systems.
Managing change, deviation, and CAPA processes.
Preparing and supporting internal and external audits.
Conducting system health monitoring, assessing opportunities, and...
Collins McNicholas Recruitment
Leinster
4 days ago
...Preventative actions are put in place to prevent recurrence. Support lead investigators and coordinate performance review of events trending for CAPA’s and NM’s.
Review processes, facilities, procedures, and management of change documents to assure conformance to recognised EHS...
September Consulting Ltd
Leinster
4 days ago
...integrity from warehouse to production.
Lead investigations into warehouse-related deviations, managing Corrective and Preventive Actions (CAPAs), and overseeing changes to ensure compliance with regulatory standards and internal policies.
Warehouse Operations Specialist...
Life Science Recruitment
Leinster
3 days ago
...Engineer
Galway Project Manager - Suite Lead
Tipperary Senior Design Assurance Engineer
Galway Senior Manufacturing Engineer - (NC,CAPA
Limerick Product Development Engineer
Galway Process Support Specialist
Carlow Validation Specialist - 50/50 remote
Carlow...
Life Science Recruitment
Leinster
2 days ago
...Management Systems(eQMS) related, but not limited to the following processes: Documentation management, Change controls, Deviation management, CAPAs, Customers complaints and Laboratory Investigations.
· Lead and execute development and /or modification of the company’s eQMS.
·...
Cpl Healthcare
Leinster
4 days ago
...actions are put in place to prevent recurrence.
Support lead investigators and coordinate performance review of events trending for CAPA’s and NM’s.
Review processes, facilities, procedures, and management of change documents to assure conformance to recognised EHS regulations...
Tandem Project Management Ltd.
Leinster
2 days ago
...release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e....
Life Science Recruitment
Leinster
5 days ago
...Kilkenny, you can shape your career as you help shape the future of healthcare.
This is how you can make a difference at Abbott:
As a CAPA Engineer you will facilitate and execute the CAPA process. You will also support continuous improvement and effective maintenance of...
Abbott Laboratories
Kilkenny, Co. Kilkenny
3 days ago
...testing in preparation for QA Specialist or Qualified Person disposition activities
* Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and...
Dublin
7 days ago
£51.6k - £59.4k per annum
...characterization, tech transfer and validation.
* Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
* Interfaces with manufacturing as well as all support functions to provide robust and coordinated support...
Dublin
9 days ago
...and industry standards.
· Perform routine entries in the local calibration maintenance software.
· Participate in deviations, CAPA’s and change control’s related to the maintenance of instruments in alignment with team priorities.
· Provide support to maintain a...
€50k - €60k per annum
...deviations, non-conformances, and customer complaints, leading root cause analysis and implementing corrective and preventive actions (CAPAs) to prevent recurrence.
* Perform risk assessments and quality risk management activities to identify and mitigate potential risks to...
AVANSEL RECRUITMENT IRELAND
Wicklow Town, Co. Wicklow
9 days ago
€50k per annum
...Team player who can work effectively and proactively on cross-functional teams.
Experience/understanding of complaint handling or CAPA processes are desirable
Must have excellent communication skills both oral and written.
Auditing experience to the requirements of...
Dublin
8 days ago
€35k - €40k per annum
...Action/Preventative Action Process
Drive continual improvement across the organisation by leading, supporting and promoting the business CAPA (Corrective and Preventative Action) process as required
Support any IMS projects as required
Other duties as may be required...
...have experience in Quality Assurance within a medical device company or pharmaceutical field.
Experience with regulatory affairs and CAPA an advantage.
Knowledge of Regulatory Requirements (MDD/MDR or FDA) an advantage
Key Competencies
Must have a flexible...
...Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
· Co-ordinate NCR / CAPA Process to ensure timely resolution and closure of issues.
· Lead training activities on Quality Procedures, e.g., Compliance, GMP,...
Cpl Healthcare
Leinster
2 days ago
...Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimise risk.
Co-ordinate NCR / CAPA processes to ensure timely resolution and closure of issues.
Lead training activities on Quality Procedures, e.g., Compliance, GMP,...
Matrix Recruitment Group
Leinster
4 days ago
...requirements for example CSV and SDLC.
Support the review & approval of key quality deliverables including SDLC Change control Deviations CAPAs. Etc.
Attend periodic review meetings cutover migration hyper care support any enhancements planning design and/or implementation...
...coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints
Perform CAPA reports
Support clients in product submission to applicable regulatory authorities
Support Quality Department in implementing and...
...Operations
~Audit quality practices and processes within the site focusing on the prevention of deviations
~Assisting to develop the site CAPA process including assignment of effective RCA’s (root cause actions) for all process deviations to the appropriate owners and driving...
...Conduct or coordinate investigations, root cause analysis, and implementation of corrective and preventive actions for customer complaints, CAPA, and non-conformances.
Oversee and approve all phases of assigned events and investigations to ensure thoroughness and accuracy....
...assessments and changes ensuring appropriate actions are implemented timely.
Provide QA review and approval of Change Controls Deviations/CAPAs SOPS and related documentation for compliance to GMP and site requirements at the facility.
Provide QA oversight to GMP readiness...
...of six sigma LEAN and root cause analysis tools used for identifying and correcting deviations.
Day to day management of Deviation CAPA and Change Control metrics
Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a...
...required.
Acting as a delegate for the Quality Lead.
Lead investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering.
Leading and implementing significant process...
Collins McNicholas Recruitment
Leinster
2 days ago
...characterization tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to...
...Engineering, Computer Systems or Science discipline.
~ A minimum of 2 years experience in full Software Lifecyle activities / SDLC, CAPA systems, ALCOA Principles, and leading on quality software projects ideally in Medical Device or Pharmaceutical manufacturing
~ Proficient...
...of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
Day to day management of Deviation CAPA and Change Control metrics
Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a...
...reliability and efficiency of manufacturing processes in addition to daytoday support related to unplanned event troubleshooting investigations CAPA identification and implementation.
Requirements
Primary responsibilities:
Perform as a knowledgeable subject matter expert...
...issues.
Contribute to the development and maintenance of the company's QMS, including the Corrective and Preventive Actions process (CAPA).
Assist in implementing plant-wide quality system improvements.
Maintain the internal audit schedule, conduct internal Quality...
County Meath
22 days ago