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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality Technician

Quality Technician RK21116 11 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The QC Technician responsibilities include, but are not limited to the following: Receive and manage samples that come into the lab for stability, in-process and release testing. Reagent preparation, cleaning, and routine ...

Location: Dublin,
Quality Technician
Dublin Not Disclosed

Associate Quality Specialist

Associate Quality Specialist RK21125 Contract – 12 months Tipperary We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: Participate as functional expert in the cross functional team that manages production right first time. Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated C...

Location: Tipperary,
Associate Quality Specialist
Tipperary Not Disclosed

Quality Operations Specialist

Quality Operations Specialist AMC21064 Contract – 11 months Swords We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role will provide direct Quality support to production areas as part of the Integrated Product Team. You will ensure quality and compliance of manufactured products and will represent quality on the shop floor in a busy biotechnology manufacturing site. If y...

Location: Dublin North,
Quality Operations Specialist
Dublin North Not Disclosed

QA Director of Operations

QA Director of Operations Our client, a global biologics organisation are currently recruiting for a QA Director of Operations to join their team on a permanent basis. The QA Director will direct quality oversight of products manufactured and tested on site, from introduction through to product release. As QA Director, you will be responsible for all aspects of Quality activities associated with daily operations and future site and global strategic design. The QA Director will proactively identify and minimize product quality and compliance risks by establishing ...

Location: Louth,
QA Director of Operations
Louth Not Disclosed

Senior Quality Engineer

Title: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer
EU Not Disclosed

Quality Manager

Job title: Quality Engineer/ Quality Manager Location: ATU Ihub, Galway Company: My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval. Overview: As a Quality Engi...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Quality Manager
EU Not Disclosed

QA Representative API External Manufacturing

QA Representative API External Manufacturing Our client, a global manufacturing pharma organisation, are currently recruiting for a QA Representative to join their Cork based team on a permanent basis. As QA Rep, you will provide support for the quality activities at Contract Manufacturing organizations (CMOs). This role will involve international travel to ensure that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Around 20% travel is anticipated. Responsibilities S...

Location: Cork,
QA Representative API External Manufacturing
Cork Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager
EU Not Disclosed

Quality Systems Manager

Company: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager
EU Not Disclosed

Associate Quality Specialist

Associate Quality Specialist RK20103 Contract – 11 months Tipperary We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: • Participate as functional expert in the cross functional team that manages production right first time at Ballydine. • Review and approve batch, cleaning and testing documentation. • Ensure that all Labo...

Location: Tipperary,
Associate Quality Specialist
Tipperary 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.