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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

Quality & Compliance Specialist (Distribution)

Our client is a leading distributer of Clinical, Pharmaceutical & Medical equipment & consumables. They are currently seeking a Quality Systems & Compliance Specialist to join an established team in their offices in Tipperary. This is a permanent full time role. The successful person shall report to the Director of operations. RP qualification is desirable, but not essential. Experience of Quality implementation & internal auditing from a distribution/ Medical device or Pharmaceutical background is essential. Role/Responsibilities: o Implement%2...

Location: Tipperary,
Quality & Compliance Specialist (Distribution)
Tipperary Not Disclosed

Senior QA Specialist

A Senior QA Specialist is required to join a leading Biopharmaceutical business in Limerick. The focus of this role is to perform and lead activities in support

Location: Limerick,
Senior QA Specialist
Limerick Not Disclosed

QA Materials Supplier Specialist

A QA Materials Supplier Specialist required to join a leading global Biopharma company in Limerick. This position is an integral part of our client’s program to assure that raw materials used in manufacturing are of the appropriate quality to facilitate the production of drug products meeting or exceeding expectations. It requires working with cross-functional teams and suppliers to resolve quality issues and assure product quality The Role Work with a global supplier quality team to continually evaluate supplier performance and respond accordingly based on triggering...

Location: Limerick,
QA Materials Supplier Specialist
Limerick 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

Quality & Training Professional

Quality & Training Professional Our client, a Cork based pharmaceutical organisation are currently recruiting for Quality & Training Professional to join a new team within the organisation. As Quality and Training Professional you will ensure quality processes through established standards and monitoring activities following the customer experience principles. You will be responsible for agent performance contact monitoring and managing elements of the training administration processes. Responsibilities • Ensure the consistency and standardization of custom...

Location: Cork,
Quality & Training Professional
Cork Not Disclosed

Senior QA Operations Manager

Senior QA Operations Manager Our client, a growing biopharmaceutical organisation are currently hiring for a Senior QA Operations Manager to join their team. As Senior QA Ops Manager you will be responsible for all aspects of assigned QA Team, provides leadership and support to direct reports. You will provide QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents. Responsibilities • Responsible for all aspects of QA Team including re...

Location: Limerick,
Senior QA Operations Manager
Limerick 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
Other Quality Assurance Jobs
Job Title Location Salary Actions
Quality/Commissioning Lead Kilkenny Not Disclosed
Associate Director Quality Risk Management System Limerick Not Disclosed
Quality/Commissioning Lead Kilkenny Not Disclosed
Blood Tissue and Organ Inspector Dublin Not Disclosed
QA Specialist Cork Not Disclosed
Facilities Maintenance Director Limerick Not Disclosed
Blood Tissue and Organ Inspector Dublin Not Disclosed
QA Specialist Cork Not Disclosed
QA Specialist Cork 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.