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.
This rare opportunity is 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.
Key Responsibilities:
* To act as a QP in the Batch Release group
* Certify 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.
* 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 online inspections of packed product.
* QA review of documentation, including SOP's, worksheets, logbooks.
* Any other related activities as indicated by the Manager, QA
Requirements:
* Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC).
* QP qualification
* Experience of Quality systems to include but not limited to deviation, out of specs, risk management.