QP Delegate

START PEOPLE; Geel; On-site; EUR 80,000 - 110,000; Full time

Job summary

START PEOPLE is seeking a QP Delegate to support the Qualified Person in ensuring regulatory compliance and quality standards for batch releases of commercial and clinical products. The role relies on the site’s pharmaceutical quality system and involves detailed review of batch release dossiers.

The QP delegate approves batch release dossiers, oversees governance and escalation, and ensures alignment with deviations, change control, and export requirements within a Belgian site.

Responsibilities

• Quality & Batch Release oversight and decision making
• QP Governance & Escalation management
• Deviations & Change Control coordination
• Analytical & Product Specifications review
• Product Review and release documentation
• Shipment & Export compliance
• Reference Samples management

Job description

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