QP Delegate

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a QP delegate you act as the first QP contact point for issues within a defined manufacturing area. 
• You are part of the QA release team. 
• You provide QP-related feedback to QA engineers during early QP involvement meetings. 
• You identify deviations and/or changes that need to be escalated to the QP Governance meeting. 
• You conduct a detailed review and approve batch release dossiers. 
• You review and approve Certificates of Analysis. 
• You release commercial and clinical lots in the ERP system for shipment to Drug Product sites. 
• You review and/or approve deviations where (delegate) QP involvement is required. 
• You review and/or approve new or major updates to regulatory submissions. 
• You review and approve Product Specification Sheets. 
• You approve export certificates for product samples to be shipped to the US. 
• You review and approve the usage and/or destruction of Reference ('reserve') samples. 
• You do not certify batches in the "vrijgaveregister", as this falls outside your scope. 

Requirements

• Master's degree in Industrial Pharmacy. 
• QP number as specified in Article 84 and Article 211 of the Royal Decree of December 14, 2006.
• 8-10 years of experience in the pharmaceutical industry. 
• Prior experience as a Qualified Person (QP). 
• Experience in biotechnology production processes.
• Fluent in Dutch and English.

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.