A leading Irish healthcare group are currently recruiting a Quality Officer to manage, operate and develop their quality management systems. This permanent position will ensure that excellent standards of quality are maintained throughout the business processes and the standards are continuously monitored and improved.
Management, operation and development of the quality systems deployed on site.
Achievement of quality performance objectives.
Ensuring the adherence of all activities to the requirements of our quality management systems.
Fostering of a quality driven culture within the business.
Working closely with individual managers and staff across the group to proactively assist them in addressing non-conformances and enhancements to procedures in their area of responsibility.
Fostering of a commercially orientated quality driven culture across the group.
Management of CAPAs, internal and external audits and the risk management process.
Management of quality actions with customers and suppliers, this includes product recall and adverse event reporting processes.
Ensuring adherence to the requirements of the Group’s Pharmaceutical Licensing requirements.
Liaison with external regulatory bodies on all quality and regulatory related matters, in particular the National Standards Authority of Ireland, the Irish National Accreditation Board and the Health Products Regulatory Authority (HPRA).
Monitoring developments and changes and to quality related regulations and how they may operations. Ensuring compliance with all such regulations.
Qualifications & Experience:
The ideal candidate will have a background in a scientific discipline or pharmaceutical industry.
3 years plus of experience in the pharmaceutical and/or medical device industries. Specific experience working in a quality systems or quality assurance role is a requirement for this position.
Preferred Experience, but all not essential with ISO 90001, GDP, ISO 13485, ISO 17025