QP Delegate

The QP Delegate serves as a key quality assurance representative, supporting the Qualified Person (QP) in ensuring compliance with regulatory requirements and internal quality standards for the release of commercial and clinical batches. While the QP delegate has the responsibility for approving the batch release dossier based on a detailed review of the batch release dossier content, the QP delegate relies on the pharmaceutical quality system of the site under the responsibility of the Qualified Person.

Key Responsibilities

Quality & Batch Release QP Governance & Escalation Deviations & Change Control Analytical & Product Specifications Product Review Shipment & Export Reference Samples Education:

Master of Industrial Pharmacy Certification:

• Valid QP number - recognized by the Belgian Minister of Health as Qualified Person as published in the Belgian official journal.
• QP initial training must be completed and kept up to date as described in QU-SOP-0037724.

Experience

Minimum 8–10 years in the pharmaceutical industry; prior experience as a QP is strongly preferred; extensive knowledge of and experience in biotechnology production processes Languages: Fluency in both Dutch and English is required