Qualified Person West of Ireland – Sligo Pharmaceutical Permanent CPL recruitment are once again delighted to support our key client in sourcing a QP for this biopharmaceutical site in Sligo. For this hire, they are looking for someone with a solid background in quality who is keen to establish themselves as a QP. This is a 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 group.Certify medicinal products 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 QA operational duties relating to product disposition.Participate in investigations and risk assessments related to manufacturing deviations and changes, ensuring appropriate actions are implemented.Ensure product release procedures comply with current regulatory and company requirements.Coordinate deviation investigations, log trend deviations, and issue regular reports on such trends.Act as a point of contact for Production, Engineering, QC, and Technical Affairs GMP issues.Advise and provide input into quality systems across the plant.Coordinate sampling activities for incoming materials.Coordinate the release of packaging materials on completion of testing.Coordinate the on-line inspections of packed products.QA review of documentation, including SOPs, worksheets, and logbooks.Any other related activities as indicated by the Manager, QA.The 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 qualification.Experience of Quality systems including but not limited to deviation, out of specs, and risk management.For a confidential discussion, please reach out to ****** or call me on 087 4671309.
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