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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality Manager-Medical Devices

Quality Manager-Medical Devices Our Dublin based client are currently recruiting for a Quality Manager to join their team on a permanent basis. As Quality Manager you willlead, maintain, and continuously elevate the Quality Management System (QMS). You will hold direct oversight of quality assurance, risk management, supplier quality, and regulatory obligations as a legal manufacturer of medical devices. Where formally appointed, you will also serve as the designated Person Responsible for Regulatory Compliance (PRRC) under Article 15 of Regulation (EU) 2...

Location: Dublin,
Quality Manager-Medical Devices 		Dublin Not Disclosed

Quality Manager / PRRC

Quality Manager / PRRC Our client, a speciality Pharma company are currently recruiting for a Quality Manager and PRRC to join their team on a permanent basis. The role will primarily cover the management of quality systems for Medical Devices, as well as GDP Compliance for the Medicinal product. The role is based in Dublin City Centre with hybrid working. Responsibilities: Quality Management System • Manage & maintain the Quality Management System (QMS) • Create new SOPs and other quality documents • Carry out risk assessm...

Location: Dublin,
Quality Manager / PRRC 		Dublin Not Disclosed

Quality Manager RP

Quality Manager & Responsible Person (RP) Our client are hiring a Quality Manager & Responsible Person (RP) to oversee their GDP Quality Management System and maintain compliance across their wholesale distribution sites. Key Responsibilities: Maintain and oversee the company’s GDP Quality Management System, SOPs, and regulatory compliance. Act as the primary contact for the HPRA and lead regulatory inspection readiness and audits. Serve as the Controlled Drug Responsible Officer for specified distribution facilities. Oversee supplier/c...

Location: Dublin,
Quality Manager RP 		Dublin Not Disclosed

Senior Associate Quality Control

Senior Associate Quality Control AS3646 12 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. Duties: • Plan and perform analyses with great efficiency and accuracy. • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. • Report, evaluate, back-up/archive, t...

Location: Dublin,
Senior Associate Quality Control 		Dublin Not Disclosed
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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.