Qualified Person (QP)

AssureBio is looking for a Qualified Person (QP) to join one of our clients, a pharmaceutical manufacturer of generic medicines.

This is an excellent opportunity for a newly qualified or experienced Qualified Person (QP) who wants to play an important role in leading the organisations batch certification, regulatory compliance, maintaining quality systems, supervising personnel and processes, managing audits, and providing guidance on product development and safety issues.

 Job Summary

• Compliance and Product Release: Ensure products comply with EU directives and GMP guidelines, approve batch releases, and act as Qualified Person (QP) for product release.
• Quality Assurance: Manage and review the quality management system, identify improvements, address deficiencies, and review third-party audit reports and annual product quality reviews.
• Regulatory Compliance: Stay updated with regulatory changes, manage device technical files, ensure compliance with regulations, and host MHRA inspections.
• Issue Management: Record and address complaints and adverse incidents, and manage data systems for compliance and customer satisfaction.
• Oversight: Supervise QC, QA, and regulatory personnel, ensure training, and oversee validation systems for equipment, processes, and methods.
• Supplier and Material Approval: Approve and monitor suppliers, starting materials, packaging components, and review manufacturing documents.
• Audits: Perform internal and external audits, maintain audit schedules, and review and approve annual product reviews.
• KPI Implementation: Implement and monitor Quality KPIs, and manage quality management review meetings.
• Advisory Role: Provide advice on new product development and regulatory submissions, liaise with QPPV on safety information, and ensure MHRA approval for license variations.