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Search Results for Quality Specialist
Job Title. Location Salary Actions

GCP/Pharmacovigilance Inspector

Our client is regulatory authority who are based in Dublin. They are seeking a GCP/ Pharmacovigilance Inspector to join an established team on a 2 year contract. Reporting to the GCP/Pharmacovigilance Inspection Manager, the role of an Inspector is to evaluate the compliance of sites inspected, both in Ireland and internationally, with the requirements of National legislation (in Ireland), European community directives, regulations and guidance. These include: Hospitals, Clinics, healthcare centres, clinical research facilities, sponsor organisations, CROs, C...

Location: Dublin,
GCP/Pharmacovigilance Inspector
Dublin Not Disclosed

Senior QA Assoicate

Would you like to join a leading and well-known pharmaceutical company in Dublin, to further develop your career? This is an excellent opportunty to work on leading technologies in the biotech industry. As a Senior Quality Assurance Associate, you will be theQuality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement...

Location: Dublin,
Senior QA Assoicate
Dublin Not Disclosed

Senior Source Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork . The Senior Source Quality Engineer is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Travel Opportunities: EU based travel may be required. Your duties: Provide overall quality assurance leadership in the management of suppliers engaged in the production of products. Provide complex product team support for quality system design and audit, compliance assessment%...

Location: Cork,
Senior Source Quality Engineer
Cork Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Project Manager UDI Republic of Ireland Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
Director, Quality & Compliance (GCP) Dublin Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
Project Manager UDI Republic of Ireland Not Disclosed
Director of Quality Risk Management System Limerick Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
Associate Quality Engineer Dublin Not Disclosed
Project Manager UDI Republic of Ireland Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
Project Manager UDI Republic of Ireland 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.