Qualified Person West of Ireland – Sligo Pharmaceutical Permanent CPL recruitment are once again delighted to support our key client in to source a QP for this biopharmaceutical site in Sligo.
For this hire they are looking someone that has a good solid background in quality and that is keen to get established as a QP.
Rare opportunity not to be missed.
You will support the Manager, QA in the day to day running of the QA department, with a particular emphasis on batch disposition and the supervision of related quality systems.
To act as a QP in the Batch Release groupCertify medicinal product in accordance with requirements of product marketing authorization, Article 97 Veterinary Medicinal Directive 2019/6, and EU GMP Annex 16.Assist in the coordination of the QA operational duties relating to product disposition.
Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.
Ensure product release procedures comply with current regulatory and company requirements.
Coordinating deviation investigations, log trend deviations and issuing regular reports on such trends.
Acting as a point of contact for Production, Engineering, QC and Technical Affairs GMP issues.
Advising and providing input into quality systems across the plant.
Coordinating sampling activities for incoming materialsCoordinating the release of packaging materials on completion of testingCoordinating the on-line inspections of packed productQA review of documentation, including SOP's, worksheets, logbooks.
Any other related activities as indicated by the Manager, QAThe successful applicant will possess the following knowledge, skills, qualifications and experience.
Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC).QP qualificationExperience of Quality systems to include but not limited to deviation, out of specs, risk management.
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