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GMP Inspector
Dublin
Quality Engineer
Dublin South
CTO
Galway
Supply Chain Analyst
Dublin North
R&D Engineer
Dublin
API Purchaser
Dublin
Consultant
Cork
Snr QA Specialist
Dublin South
Administration Support
Dublin North
Project Engineer
Dublin North
Program Manager
Westmeath
Risk Manager
Dublin
R&D Engineer
Galway
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Quality Specialist
Job Title. Location Salary Actions

GMP Inspector

GMP Inspector Reporting to a GMP Inspection Manager, the GMP Inspector will be responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The Manufacturing Compliance Specialist will evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation European Community Directives, Regulations and Guidance. These sites may include; • Manufacturers and distributors of medicinal products. • Manufacturers of investigational medicinal products. • Sites involved in ...

Location: Dublin,
GMP Inspector
Dublin Not Disclosed

Scientific Officer QDR

ROLE SUMMARY Reporting to the Quality Defects and Recall Manager, the Scientific Officer works within the Quality Defects & Recall Programme of the Market Compliance section. The role includes performing risk-based technical evaluations and assessments of suspected and confirmed Quality Defect reports on medicines. The Scientific Officer reviews and/or recommends actions which are designed to remediate and correct the non-compliance issue at hand, to ensure patient and animal safety. The Scientific Officer works closely and maintains effective working relationships with the ...

Location: Dublin,
Scientific Officer QDR
Dublin Not Disclosed

Senior Quality Engineer

SENIOR QUALITY ENGINEER Our Client, One of the largest medical device companies based in Galway is currently recruiting Senior Quality Engineer . The successful candidate will lead and work as part of a team to maintain high quality and performance standards on all Medical products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision. The Role • Lead and drive QA initiatives within area of functional responsibility. • Provide quality inpu...

Location: Galway,
Senior Quality Engineer
Galway Not Disclosed

Senior R&D QA Executive

Senior R&D QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for Senior R&D QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with QA/QC with good knowledge of product development. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include re...

Location: Galway,
Senior R&D QA Executive
Galway Not Disclosed

QA Executive

QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with more than 5 years relevant experience in Quality. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include review and approval of change controls, no...

Location: Galway,
QA Executive
Galway Not Disclosed

Quality Specialist

Quality Specialist Our Client are a global BioPharmaceutical company committed to scientific excellence and/or Research & Development innovation to bring

Location: Dublin,
Quality Specialist
Dublin Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Laboratory Supervisor Westmeath Not Disclosed
Quality Assurance Specialist (QA, full-time) Dublin See description
QC Lab Analyst Sligo Not Disclosed
Quality Assurance Specialist Dublin West €45000 - €50000
Quality Assurance Specialist Dublin West €45000 - €50000

Quality Specialist Career Profile

Quality Specialist


The Quality Specialist is responsible for the review, approval and processing of document change requests, assisting in the development and maintenance of the quality management system, acting as Lead Auditor, developing quality KPIs and supporting the complaint handling process. Typically the QA Specialist will have a degree in Life Science or Pharmacy and have 2-3 years experience in the area of quality assurance and will ideally have experience within the quality departments of a Medical Device company or a regulatory agency.
Key responsibilities of the Quality Assurance Specialist

  • Ensuring that area procedures are correct and updated as necessary.
  • Review of document change requests to evaluate each change for quality related issues.
  • LMS administrator for QA function.
  • Assist in the development and maintenance of the quality system as required, ensuring compliance to ISO13485:2003.
  • Provide guidance to Technical Service and Customer Service on quality system issues.
  • Contribute to making the operation efficient and compliant by effective liaison with all departments in quality matters.
  • Facilitate internal audits of the systems and processes on a regular basis as performed by the internal audit team. Act as Lead Auditor.
  • Participate and report at management review and assist in resolving issues that may arise.
  • Conduct QMS training for all employees.
  • Participate in the development of the department KPIs. Assist in the preparation of internal statistical reports (KPIs).
  • Schedule, chair and report at routine quality focused meetings influencing change and developing best practices.
  • Function as QA support in handling Corrective and Preventive Action requests in the internal CAPA system.
  • Liaise with external groups in relation to complaint handling systems i.e. complaint investigation centres and complaint management centres.