QP Consultant

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

• First QP contact point for issues in a defined manufacturing area Provide QP related feedback to QA engineers during early QP involvement meeting Identifies deviations and/or changes that need to be escalated to the QP Governance meeting
• The detailed review and approval of the batch release dossiers Review and approval of Certificates of Analysis Release of Sanofi Geel commercial and clinical lots in the ERP system for shipment to Drug Product sites
• Review and/or approval of deviations where (delegate) QP involvement is required
• Review and/or approval of new or major updates to regulatory submissions
• Review and approval of Product Specification Sheets Approving export certificates of product samples to be shipped to US Approving shipment of product to Sanofi sites or Partner sites for purposes other than per existing agreements
• Review and approval of the usage (in exceptional case) and/or destruction of Sanofi Geel Reference (‘reserve’) samples, and approval of the request to provide Reference (‘reserve’) samples to regulatory agencies

Requirements

• Education: Master of Industrial Pharmacy QP number (Dient nummer te hebben van de “Lijst der bevoegde personen voorzien in artikel 84 en artikel 211 van het koninklijk besluit 14 december 2006 betreffende geneesmiddelen voor menselijk en diergeneeskundig gebruik”)
• Required Experience: Min 8-10 years experience in pharmaceutical industry, preferably acted already as a QP Extensive knowledge & experience in biotechnology production processes
• Languages: Required to be 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.