Job Description
We are seeking a highly skilled Qualified Person (QP) to support our QA Manager in the day-to-day operations of the Quality Assurance department at our biopharmaceutical site in Sligo, West of Ireland.
Key Responsibilities:
* Act as QP in the Batch Release group
* Certify medicinal products in accordance with marketing authorization requirements 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
* Evaluate product release procedures for compliance with regulatory and company requirements
* Coordinate deviation investigations and issue regular reports on trends
* Serve as a point of contact for Production, Engineering, QC, and Technical Affairs GMP issues
* Advise on quality systems across the plant
* Coordinate sampling activities for incoming materials
* Release packaging materials after testing completion
* Conduct online inspections of packed products
* Review documentation, including SOPs, worksheets, and logbooks
Requirements:
* Experience working in a pharmaceutical manufacturing environment in a Quality capacity (QA or QC)
* Hold QP qualification
* Knowledge of quality systems, including deviation, out-of-spec, and risk management processes
About Us:
{company} is a leading provider of recruitment services in the pharmaceutical industry. We are committed to supporting our clients in finding top talent to drive their business forward.
Estimated Salary: €80,000 - €100,000 per annum, depending on experience.