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Search Results for Quality Specialist
Job Title. Location Salary Actions

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

Technical Writer Senior Associate

A Senior Associate Technical writer – Supply Chain is required to join a leading global Biopharmaceutical business in Dublin. The role will be responsible for leading, coordinating, contributing to and undertaking activities pertaining to Supply Chain Deviations, Corrective/Preventive Actions and Change Controls. The role will provide technical expertise with a focus on Compliance and Continuous Improvement while implementing a Lean Culture and Right First Time (RFT). The role also represents the Supply Chain unit by liaising with internal and external customers. Prim...

Location: Dublin,
Technical Writer Senior Associate
Dublin Not Disclosed

Quality and Customer Experience Specialist

Quality and Customer Experience Specialist Our Cork based pharmaceutical client are currently recruiting for a Quality and Customer Experience Specialist. As

Location: Cork,
Quality and Customer Experience Specialist
Cork Not Disclosed

Senior Quality Engineer

Senior Quality Engineer The Senior Design Assurance Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The Senior Design Assurance Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry. The position requires a self-motivated, self-d...

Location: Limerick,
Senior Quality Engineer
Limerick 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
Other Quality Assurance Jobs
Job Title Location Salary Actions
Blood Tissue and Organ Inspector Dublin Not Disclosed
QA Specialist Cork Not Disclosed
QA Specialist Cork Not Disclosed
Associate Director QA Medical Devices Limerick Not Disclosed
Associate Director Quality Risk Management System Limerick Not Disclosed
Blood Tissue and Organ Inspector Dublin Not Disclosed
Associate Director QA Medical Devices Limerick Not Disclosed
Blood Tissue and Organ Inspector Dublin Not Disclosed
QA Director, Europe Dublin Not Disclosed
QC Lab Analyst Sligo 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.