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Fastnet The Talent Group

Job Title

QA Officer - Gdp


Responsibilities. Responsible for providing support in the maintenance and improvement of the local Quality Management System. Supporting the development and implementation of improved quality reporting measures as required. Review Annual Product Quality Reviews for all Ireland products. Creation and maintenance of all Product Quality Review schedules as required annually. Review all incoming batches of product for market release onto the Irish market. Liaising with the local primary wholesaler in order to ensure efficient release of batches for sale to the Irish market. Maintenance of a record system for product certificates of analysis and batch release certificates for incoming batches. Providing training in all aspects of Quality Management Systems to both office and field based staff. Responsible for maintaining documented training records. The collection and coordination of quality related customer complaints, liaising with external sites in order to close out such complaints. Effective management and control of deviations, change controls and CAPAs. Quality review and approval of Artwork components. Monitoring artwork used on stock being released onto the market to ensure compliance if required. Interface between Regulatory Affairs, Marketing and Customer Service personnel. Leading Quality based projects working as part of a multidisciplinary team as required. Conduct self-inspections and external audits if required. Provide direct support during customer, supplier, regulatory and both internal and external audits as applicable. Review and approval of regulatory documentation if required. Support and assist RA department in preparing regulatory related SOP. Providing support to ensure variations have been implemented for the market. Provide support for all medical information queries and adverse events received by the company in ensuring that they are passed on to the medical information team in the UK. Support to the Responsible Person and Deputy Responsible Person to ensure compliance with EU Guidelines on Good Distribution Practice of Medicinal Products. Requirements. BSc in relevant area. Comprehensive experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry. Experience and understanding in the area of Product Quality Reviews. Knowledge of EU quality related pharmaceutical regulations including both GDP and GMP legislation. Experience of conducting quality based investigations and root cause analysis. Experience of conducting self-inspections. Understanding and experience of deviations, change control, root cause analysis and CAPA's. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on



Date Added

104 days ago