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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