We are seeking a qualified individual to fill the position of Qualified Person at our biopharmaceutical site in Sligo, West Ireland.
Job Summary
This is a rare opportunity for an experienced quality professional to join our team and take on the role of Qualified Person. The successful candidate will be responsible for supporting the Manager, QA in the day-to-day running of the QA department.
Main Responsibilities
* Act as a QP in the Batch Release group
* Certify medicinal products in accordance with product marketing authorization requirements, Article 97 Veterinary Medicinal Directive 2019/6, and EU GMP Annex 16
* Assist in coordinating QA operational duties related to product disposition
* Participate in investigations and risk assessments related to manufacturing deviations and changes
* Ensure product release procedures comply with current regulatory and company requirements
* Coordinate deviation investigations, log trends, and issue regular reports
* 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 products
* QA review of documentation, including SOPs, worksheets, and logbooks
Requirements
* Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC)
* QP qualification
* Experience of quality systems, including deviation, out-of-spec, and risk management