Search Results: 245 vacancies
...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
20 hours ago
£ 345 - 517 per day
...communication, organizational, and decision-making skills.
Proven experience in a similar role within the Bio-Pharmaceutical Manufacturing Laboratory domain.
Knowledge of 21 CFR Part 11, 210, 211, 820 (Quality System Regulations), FDA, Risk Assessment, GAMP 5, Change Control, CAPA, etc
Cork
24 days ago
...Supporting change controls and Executing test plans for changes to BMRAM qualified systems.
* Completing Corrective and Preventative Actions (CAPA) associated with BMRAM and asset management in a timely manner.
* Provide guidance and support to colleagues relating to initiation...
Limerick
18 days ago
...and instrumentation.
* Support the QC department for troubleshooting, investigations, and deviations as an SME.
* Manage deviations, CAPA’s and change control’s related to QC systems and instrumentation and team
* priorities.
* Author and revise local SOPs, work...
Dublin
18 days ago
...Continually seeks to drive improvements in product and process quality.
Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Evaluates new equipment and processes and participates in the transfer of new products....
...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...
...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...
...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...
...efforts,
Heavily involved in the coordination, building and approval of the site PQR requirements,
Write, Review or Approve site CAPAs, LIRs and Complaints,
Compile and Deliver quarterly Quality Management review for AbbVie North Dublin,
Conduct Internal and...
...multiple stakeholders of the organisation including suppliers, transport companies, internal and external personnel etc.
Deviation, CAPA & Change Control - take ownership for any minor deviations, CAPA's or Change Control as delegated by the Supply Chain Manager.
Knowledge...
€60k - €75k per annum
...applicable International Regulations
Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training).
Monitor compliance with companies policies, procedures and applicable regulatory requirements,...
...Supports in the development and upgrade of engineering procedures, template, and forms, to ISO9001 and en1090 standards.
May own and lead CAPA and NCE activities.
Role Requirements:
A degree in a relevant engineering subject is required.
Minimum of 5 years’ experience...
€55k - €60k per annum
...material commodity price trends and supply / demand situations which may impact the business.
Manage relevant change controls, deviations, CAPA's etc. to meet the requirements of the Quality management system.
Collaborate with Project managers and stakeholders to understand...
...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...
...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...
€ 60 - 67 per hour
...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,...
...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...
...pharmaceutical company with offices in Dublin, we are collaborating with them on a new vacancy for a Quality System Specialist (Deviations and CAPAs)
The primary purpose of this position is the management of the Quality System functions in the organisation in relation to...
...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,...
...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...
