QP Delegate

Job description

QP Delegate Locatie: Geel Level: L2-2 Hiring manager: Gunter Aerts About the Role 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• Acts as the first QP contact point for quality-related issues• Performs detailed review and approval of batch release dossiers• Reviews and approves Certificates of Analysis / Certificates of Conformity• Changes the Usage Decision in the ERP system for Sanofi Geel commercial and clinical (F)DS batches QP Governance & Escalation• Provides QP-related feedback to QA Engineers during early QP involvement meetings• Identifies deviations and/or changes requiring escalation to the QP Governance meeting Deviations & Change Control• Reviews and/or approves deviations and/or change controls (with regulatory and/or quality impact) where QP (Delegate) involvement is required• Approves the retest plan of OOS results• Reviews and/or approves new or major updates to regulatory submissions Analytical & Product Specifications• Approves the analytical batch abstract for Sanofi Geel QC testing of clinical/commercial products manufactured on (or under the responsibility of) other Sanofi sites• Approves (Formulated) Drug Substance Specification Sheets Product Review• Reviews Periodic Product Review Shipment & Export• Approves shipment of product (samples) to Sanofi sites or Partner sites for purposes other than per existing agreements Reference Samples• Approves the usage (in exceptional cases) and/or destruction of Sanofi Geel Reference ('reserve') samples• Approves the request to provide Reference ('reserve') samples to regulatory agencies About You Education: Master of Industrial Pharmacy Certification: Valid QP number - recognized by the Belgian Minister of Health as Qualified Person as published in the Belgian official journal. QP initial training must be completed and kept up to date as described in QU-SOP-0037724. Experience: Minimum 8–10 years in the pharmaceutical industry; prior experience as a QP is strongly preferred; extensive knowledge of and experience in biotechnology production processes Languages: Fluency in both Dutch and English is required Pursue Progress. Discover Extraordinary.Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! The salary range for this position is :€0,00 - €0,00Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.