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Search Results for Quality Assurance Officer
Job Title. Location Salary Actions

Quality Manager

Quality Manager Our client, a large regulatory body requires a Quality Manager to join their team. The Quality Manager will be responsible for the implementation and continuous improvement of the Quality Management System in line with European and International standards. Responsibilities • Implement and further develop the quality management system • Manage the complaints procedure and the protected disclosure procedure • Design, implement and oversee the document and records management system • Maintain the systems and procedures for data pro...

Location: Dublin,
Quality Manager
Dublin Not Disclosed

Quality Management Systems Specialist

Our client is a the leading medical device distributor across Ireland and the U.K. They are seeking a QMS Specialist with a minimum of 1 years previous experience. The QMS Specialist will report to the QCRA Manager across the Healthcare Group to support their Quality Management System requirements. This role will require occasional travel between offices in Dublin, Belfast and Great Britain. A full, clean drivers licence is required. This role requires a person who is capable of developing strong internal customer relationships between their various sites. Role/Responsibil...

Location: Dublin,
Quality Management Systems Specialist
Dublin Not Disclosed
Other Medical Affairs Jobs
Job Title Location Salary Actions
QC Trainer Cork Not Disclosed
Fluent German Medical Information Product Specialist Cork Not Disclosed
Fluent German Medical Information Product Specialist Cork Not Disclosed
Associate Sourcing Director Limerick Not Disclosed

Quality Assurance Officer Career Profile

Quality Assurance Officer

The role of the Quality Assurance (QA) Officer within the Medical Affairs department differs from that of a QA Officer within a manufacturing environment. They are tasked with Quality Assurance at a corporate level and must develop and maintain quality systems for both Medical Affairs and the Sales and Marketing departments. They follow quality guidelines from the Irish Pharmaceutical Healthcare Association (IPHA), the Irish Medicines Board (IMB) and from Global HQ.

Typically the QA Officer 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 of QA within the commercial or medical affairs departments of a pharmaceutical company or a regulatory agency.

Key responsibilities of the Quality Assurance Officer

  • In conjunction with the Quality Manager, local Regulatory Advisor and local Medical Advisor, ensure that the sales and marketing element of the company is compliant with all IPHA, IMB and internal quality requirements
  • Update and where necessary write SOPs to act as guidance for the affiliate to ensure that the company are compliant with quality guidelines
  • Devise and implement a process map for all current quality systems in the affiliate and update this as new systems
  • Hold monthly compliance meetings to review status of quality adherence in the company and to identify potential areas for improvement
  • Carry out audits of quality systems locally are specific intervals to ensure that they are effective and to carry out CAPAs where necessary
  • Train all staff members on relevant areas of quality to their function as outlined in the training manuals
  • Maintains all quality documents and records in an up to date manner
  • Represents the company to the IMB and in conjunction with the General Manager and Quality Manager on all matters relating to quality
  • Updates and implements elements of the local Risk Management Plan
  • Liaises with the Pharmacovigilance and Medical Information divisions to ensure that all reports are completed for the company.
  • Act as a lead on quality matters in the company and with the General Manager and Quality Manager to set a standard for all staff in the company