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 Aisling.murray@cpl.ie or call me on 087 4671309.
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