Key Responsibilities:
* To act as a Qualified Person in the Batch Release group
* Certify medicinal products in accordance with 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
* Ensure product release procedures comply with current regulatory and company requirements
* Coordinate deviation investigations, log trends and issue regular reports
* Serve as a point of contact for Production, Engineering, QC and Technical Affairs GMP issues
Requirements:
* Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC)
* Qualified Person qualification
* Experience of Quality systems including deviation, out-of-specs, risk management