Head of Quality - QP

Requirements

• including drug product manufacturing and analytical testing.
• Experience leading GMP audits
• Experience with and fundamental understanding of EMA regulations and associated guidance documents
• specifically in a leadership capacity to facilitate objective decision making
• Effective at working in fast-paced environments
• Experience interfacing with regulatory bodies or working on regulatory submissions
• Thorough understanding of quality systems and cGMPs.
• Practical experience acting as Qualified Person releasing product into the Irish and European Markets
• Qualified Person (QP) in Pharmaceutical Manufacturing Technology
• Pharmaceutical or related discipline
• biology
• BSc Degree in Chemistry
• Significant experience (5+years) leading a team within the quality assurance / quality control / compliance functions of the pharmaceutical industry.