QP Consultant

The QP delegate has the following tasks/responsibilities:

If the following job requirements and experience match your skills, please ensure you apply promptly.
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 xqknzec 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