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

Quality Assurance Officer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Waterford. 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. Duties Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirements Reviewing SOP's, as per review schedule Issuing Stability Documentation, approval of testing protocols, review of stability reports Reviewing Validation protocols & validation ...

Location: Waterford,
Quality Assurance Officer
Waterford Not Disclosed

Manufacturing deviations specialist

Manufacturingdeviations specialistrequired for a contract role with a Dublin based Biopharmaceutical facility. The manufacturing specialist will be primarily responsible for resolving fill/finish deviations. Specific responsibilities include but are not limited to: Working closely with Quality, Engineering, Process Development, Validation, Manufacturing, Inspection and Packaging to resolve deviations in a timely manner. Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Action...

Location: Dublin, Dublin South,
Manufacturing deviations specialist
Dublin Not Disclosed
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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