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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality and Customer Experience Specialist

Quality and Customer Experience Specialist Our Cork based pharmaceutical client are currently recruiting for a Quality and Customer Experience Specialist. As

Location: Cork,
Quality and Customer Experience Specialist 		Cork Not Disclosed

Medical Device Inspector

Medical Device Inspector Our Client an Irish Regulatory Body requires a Medical Device Inspector to join their Medical Device Compliance Team. Responsibilities • Plan and conduct proactive and reactive audits of manufacturers and other economic operators as part of the market surveillance activities for medical devices • Execution of audits relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities • Execution of audits arising from ongoing surveillance and monitoring programme for Notified...

Location: Dublin,
Medical Device Inspector 		Dublin 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

Quality Compliance Specialist

Quality Compliance Specialist Our client is a large scale multinational pharmaceutical company in Sydney. They are currently looking for Quality Compliance Spe

Location: Australia,
Quality Compliance Specialist 		Australia Not Disclosed

Senior QA Executive

We have a fantastic opportunity in Galway with a global Pharmaceutical company for an experienced Quality Assurance Executive(Quality Engineer) to join an estab

Location: Galway,
Senior QA Executive 		Galway Not Disclosed

Senior R&D QA Executive

Senior R&D QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for Senior R&D QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with QA/QC with good knowledge of product development. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include re...

Location: Galway,
Senior R&D QA Executive 		Galway Not Disclosed

QA Executive

QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with more than 5 years relevant experience in Quality. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include review and approval of change controls, no...

Location: Galway,
QA Executive 		Galway Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Quality Assurance Specialist Dublin Not Disclosed
QA Specialist Cork Not Disclosed
Quality Assurance Specialist II Galway Not Disclosed
Senior GMP Auditor Limerick Not Disclosed
Quality Assurance Specialist Dublin Not Disclosed
QA Specialist Cork Not Disclosed
Quality Assurance Specialist II Galway 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.