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Search Results for Quality Specialist
Job Title. Location Salary Actions

Senior QA Engineer

Senior QA Engineer Our client a high potential medical device company currently seeks a Senior QA Engineer to join their team. Reporting to the QA/RA Manager the Senior QA Engineer will support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approval. Role/Responsibilities • Working as a part of a cross-functional team to design and develop a device in line with user needs • Demonstrating and promoting a commitment to improving patient safety, custo...

Location: Dublin,
Senior QA Engineer
Dublin Not Disclosed

Quality Operations Manager, Drug Product

Quality Operations Manager, Drug Product Our client, a global pharmaceutical organisation based in Dublin are currently recruiting for Quality Operations Manager, Drug Product, to join their team on a permanent basis. Responsibilities: Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer Actively support the Product Review Committee (PRC) processes for major investigations involving Third Party products Provide quality/compliance support to the wider Supplier Relationship M...

Location: Dublin,
Quality Operations Manager, Drug Product
Dublin Not Disclosed

Quality Compliance Specialist

Quality Compliance Specialist Our pharmaceutical client are expanding their team and are currently recruting for a Quality Compliance Specialist to join them on a permanent basis. Responsibilies Assist with the QMS System set up for GDP Maintaining the Change Control system, Deviations, CAPA and Complaints and coordinating the follow up and closure of all open items. Maintaining the internal and external audit schedule and QP declarations. Assist with audits when required. Maintaining Bona Fides of suppliers and customers, including audit documentation and quality agreem...

Location: Dublin,
Quality Compliance Specialist
Dublin Not Disclosed

Quality and Regulatory Manager

Quality & Regulatory Affairs Manager Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction. Responsibilities Provide Quality & Regulatory str...

Location: Dublin, Republic of Ireland,
Quality and Regulatory Manager
Dublin Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
QA Packaging Manager/QP Dublin Not Disclosed
Quality Systems Manager Galway Not Disclosed
QA Senior Associate Dublin Not Disclosed
Senior Quality Assurance Specialist Dublin Not Disclosed
Senior QC Specialist Dublin 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.