Qualified Person Role
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Sligo, West of Ireland
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Pharmaceutical Industry
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Permanent Position
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CPL Recruitment is delighted to support our key client in sourcing a Qualified Person (QP) for this biopharmaceutical site in Sligo. We are seeking an individual with a strong background in quality and a keen interest in establishing themselves as a QP.
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Job Responsibilities:
* Support the QA Manager in the day-to-day operation of the QA department, with a focus on batch disposition and supervision of related quality systems.
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Key Accountabilities:
* Act as a QP in the Batch Release group.
* Certify medicinal products in accordance with product marketing authorization, Article 97 Veterinary Medicinal Directive 2019/6, and EU GMP Annex 16.
* Assist in coordinating 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 online inspections of packed product.
* QA review of documentation, including SOPs, worksheets, and logbooks.
* Perform any other related activities as indicated by the QA Manager.
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Requirements:
* 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.