Qualified Person

About the Role

We are seeking an experienced Qualified Person (QP) to oversee batch certification and product release activities, ensuring products are released to market in accordance with EU legislation, GMP requirements, and site quality standards. Role Type: 12 Month Contract. Hourly Rate: €69 an hour.

Responsibilities

• Certify and release licensed medicinal products in accordance with applicable EU Directives and GMP requirements.
• Manage the batch disposition process to ensure timely and compliant product release.
• Ensure batch release activities comply with site procedures, regulatory expectations, and quality standards.
• Support major investigations and ensure all product deviations and quality events are appropriately addressed before product release.
• Act as the Quality/Qualified Person representative on cross-functional project teams and committees.
• Provide expert quality guidance and support across the organisation.
• Maintain independence in all decisions relating to product quality and batch certification.
• Support audits, inspections and continuous improvement initiatives.

About You

• Eligible to act as a Qualified Person under EU regulations.
• Significant experience within a GMP-regulated pharmaceutical manufacturing environment.
• Previous experience performing Qualified Person duties, including batch certification and release.
• Postgraduate qualification (MSc or equivalent) in a relevant scientific discipline.
• Strong understanding of EU GMP requirements and pharmaceutical regulations.
• Demonstrated leadership and mentoring experience.
• Excellent communication, stakeholder management and problem-solving skills.