Search Results: 24 vacancies
...investigations and maintain compliance.
* Responsible for review and approval of the following types of documents: - Failure investigations - CAPA - SOP’s - GxP documents - Change control documents
* May lead & support root cause analysis ensuring appropriate CAPA are implemented...
Limerick
5 days ago
...requirements including supporting QP certification.
Perform and review complaints and deviation investigations change controls and CAPA s.
Creates and maintains assigned SOPs.
Compiles data for reports and presentations provides data interpretation draws...
...patient risk.
Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
Oversight and responsibility to ensure site maintains...
...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...
...reach consensus and ensure document approval timelines meet business needs.
Own and/or support GMP document-related Change Controls/CAPAs.
Skills Brief:
Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards,GAMP5, and Documentation Management/Life...
...conformances
Support and participate in external Audits (HPRA, Notified Body Audit, Customer Audits)
Provide support to Non-Conformance, CAPA, Change Controls and Documentation Control activities as required.
Participate in cross-functional teams to identify and resolve...
...inspection of vendor and internally manufactured implants for development or investigative purposes
Metrology support for complaints, NC and CAPA investigations
Inspection and calibration of internal and vendor custom gauging
Being able to challenge Vendor and Internal...
...right first time.
Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented assessed and associated CAPA identified.
Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised...
...are not limited to, the following:
Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
Acts as a...
...devices in terms of complaint investigation and risk analysis.
Participate in engineering projects in any one of the following areas - CAPA, Design, Manufacturing, EHS or NPI.
Collaborate with other Engineering teams to ensure the effective completion of all activities...
€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
Limerick
more than 2 months ago
...Lead or participate in engineering projects in any one of the following Post Market Engineering areas (detailed below) as required - CAPA or Design.
Collaborate with other Engineering Teams to ensure the effective completion of all activities associated with Post Market...
...or throughputs.
Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.
JOB REQUIREMENTS
Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering...
€80k - €85k per annum
...and regulatory requirements, including supporting QP
Perform and review complaints and deviation investigations, change controls and CAPA's.
Creates and maintains assigned
Compiles data for reports and presentations, provides data interpretation draws
Completes...
...quality results and metrics reviews including monthly quality data review process.
Completion of assigned work order notifications and CAPA’s
Participation in Audit preparation and follow-up works including during audit support
Gathers and reviews data concerning...
Abbott Laboratories
Clonmel, Co. Tipperary
1 day ago
...and QC teams to ensure product quality throughout the manufacturing process.
~Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
Regulatory Compliance:
~Stay current with industry regulations,...
...and increasing yields.
Reporting to: Manager, Post Market Engineering
Lead a team of engineers focused on the delivery of CAPA or Design projects.
Provide leadership and mentoring to team members to ensure their development and the effective completion of the...
..., Documentation Control. Validation / Qualification, Quality Agreements, Deviations and Investigations, Specifications, Batch release, CAPA, Audits, Customer Complaints
Oversee Food Safety, Hygiene and GMP standards on site
Provide guidance & support for new and on-going...
...departments.
Work closely with other departments to meet delivery requirements.
Take ownership for assigned customer complaints, CAPA’s and determine root cause.
Monitor rejects from quality control processes and disposition through MRB process.
Ensure that Cook’...
...limited to the following :
• Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
• Reviewing...
QA Resources
Limerick
2 days ago
