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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality Officer

Our client is a leading Irish healthcare group that provides sales, marketing, distribution and support services across the healthcare supply chain, operating across three core business units. They are currently recruiting a Quality Officer to manage, operate and develop their quality management systems. Role/Responsibilities: Management, operation and development of the quality systems deployed in the group. Achievement of quality performance objectives for the group. Ensuring the adherence of all activities to the requirements of our quality management systems. ...

Location: Kildare,
Quality Officer
Kildare Not Disclosed

Quality Compliance Specialist

A Quality Compliance Specialist QRM is required to join a leading global biopharmaceutical organisation in Limerick. This role supports the work of our client’s Industrial Operations and Product Supply (IOPS) site through the use of quality risk management (QRM) principles and techniques. The scope may also include collaboration with other IOPS Sites, partners, CMOs and their respective programs. The Role Ensuring compliance with all aspects of the QRM program Provide advice on all QRM matters within the IOPS organization Facilitate risk assessments Res...

Location: Limerick,
Quality Compliance Specialist
Limerick Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Associate Director Quality Risk Management System Limerick Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
QA Specialist Cork Not Disclosed
Facilities Maintenance Director Limerick Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
QA Specialist Cork Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed

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.