QP Consultant

The QP delegate has the following tasks/responsibilities:

• First QP contact point for issues in a defined manufacturing area
• Provide QP related feedback to QA engineers during early QP involvement meetings
• Identifies deviations and/or changes that need to be escalated to the QP Governance meeting
• Detailed review and approval of the batch release dossiers
• Review and approval of Certificates of Analysis
• Release of 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 the US
• Approving shipment of product to other sites or partner sites for purposes other than existing agreements
• Review and approval of the usage (in exceptional case) and/or destruction of Reference (‘reserve’) samples, and approval of the request to provide Reference (‘reserve’) samples to regulatory agencies

Required Profile:

• 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: Minimum 8-10 years’ experience in the pharmaceutical industry, preferably with prior experience as a QP; extensive knowledge and experience in biotechnology production processes
• Languages: Required to be fluent in Dutch and English