QP Delegate

h3QP Delegate /h3pLocatie: Geel /ppLevel: L2-2 /ppHiring manager: Gunter Aerts /ph3About the Role /h3pThe 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. /ph3Key Responsibilities /h3h3Quality Batch Release /h3ulliActs as the first QP contact point for quality-related issues /liliPerforms detailed review and approval of batch release dossiers /liliReviews and approves Certificates of Analysis / Certificates of Conformity /liliChanges the Usage Decision in the ERP system for Sanofi Geel commercial and clinical (F)DS batches /li /ulh3QP Governance Escalation /h3ulliProvides QP-related feedback to QA Engineers during early QP involvement meetings /liliIdentifies deviations and/or changes requiring escalation to the QP Governance meeting /li /ulh3Deviations Change Control /h3ulliReviews and/or approves deviations and/or change controls (with regulatory and/or quality impact) where QP (Delegate) involvement is required /liliApproves the retest plan of OOS results /liliReviews and/or approves new or major updates to regulatory submissions /li /ulh3Analytical Product Specifications /h3ulliApproves the analytical batch abstract for Sanofi Geel QC testing of clinical/commercial products manufactured on (or under the responsibility of) other Sanofi sites /liliApproves (Formulated) Drug Substance Specification Sheets /li /ulh3Product Review /h3ulliReviews Periodic Product Review /li /ulh3Shipment Export /h3ulliApproves shipment of product (samples) to Sanofi sites or Partner sites for purposes other than per existing agreements /li /ulh3Reference Samples /h3ulliApproves the usage (in exceptional cases) and/or destruction of Sanofi Geel Reference ('reserve') samples /liliApproves the request to provide Reference ('reserve') samples to regulatory agencies /li /ulh3About You /h3pEducation: Master of Industrial Pharmacy /ppCertification: 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
- . /ppExperience: 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 /ppLanguages: Fluency in both Dutch and English is required /ppPursue Progress . Discover Extraordinary . /ppProgress 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. /ppAt 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. /ppWatch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com /ppPursue progress , discover extraordinary /ppBetter 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. /ppAt 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. /ppWatch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com /ppThe salary range for this position is :€0,00
- €0,00 Final 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. /p