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

QA Associate - Materials Management

QA Associate My client are seeking highly motivated, talented Quality Assurance Associate to support their new Biologics Manufacturing Facility. The ideal candidate is an organised and a methodical professional who fosters a positive team environment. Main Purpose and Objectives of the Position: Provides Quality leadership, direction and governance for materials management. Assures consistent implementation of standards across the quality system. Manages quality-related matters specific to Materials Is responsible for approving appropriate quality-r...

Location: Limerick, Limerick City,
QA Associate - Materials Management
Limerick Not Disclosed

Quality Operations Specialist

Quality Operations Specialist AMC21064 Contract – 11 months Swords We’re currently recruiting for an exciting opportunity with a Biopharmaceutical 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. This role will provide direct Quality support to production areas as part of the Integrated Product Team. You will ensure quality and compliance of manufactured products and will represent quality on the shop floor in a busy biotechnology manufacturing site. If y...

Location: Dublin North,
Quality Operations Specialist
Dublin North Not Disclosed

Quality Technician

Quality Technician - QA IPT AMC20833 Contract – 11 months Shift role (4 cycle shift - 33% premium) On site - Carlow We’re currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period. Requirements Third Level Degree qualified in a Science/Technical or related discipline. Experience in sterile manufacturing environment Lean six sigma methodology experience desired Duties Perfo...

Location: Carlow,
Quality Technician
Carlow 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
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