Job Title: Qualified Person
Location: West of Ireland – Sligo
Industry: Pharmaceutical
Employment Type: Permanent
We are seeking a highly skilled and experienced Qualified Person (QP) to join our client’s team in their biopharmaceutical site in Sligo.
The ideal candidate will have a strong background in quality and be keen to establish themselves as a QP. This is a rare opportunity not to be missed.
Key Responsibilities:
* 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, 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
* Evaluate product release procedures to ensure compliance with current regulatory and company requirements
* Coordinate deviation investigations, log trends, 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 upon completion of testing
* Coordinate online inspections of packed products
* Conduct QA reviews of documentation, including SOPs, worksheets, and logbooks
* Perform other related activities as indicated by the Manager, QA
Requirements:
* Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC)
* Hold a QP qualification
* Experience of quality systems, including but not limited to deviation, out-of-specs, and risk management