Senior QP Delegate - Batch Release & Compliance

Sanofi Group

Geel

On-site

EUR 120,000 - 150,000

Full time

3 days ago
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Job summary

Sanofi Geel is seeking a QP Delegate (Location: Geel) to oversee quality and batch release activities. You will act as the primary QP contact for quality issues, review and approve batch release dossiers, and manage certificates of analysis/conformity.

Key responsibilities include QP governance, deviations/change controls with regulatory impact, and approvals of analytical specs for products. Fluent Dutch and English are essential; Master of Industrial Pharmacy and a valid QP number are required.

Qualifications

  • Master of Industrial Pharmacy is required.
  • Valid QP number and QP initial training must be kept up to date.
  • 8–10 years of pharmaceutical industry experience; QP experience preferred.
  • Fluency in Dutch and English is required.

Responsibilities

  • Acts as the first QP contact point for quality-related issues.
  • Reviews and approves batch release dossiers and Certificates of Analysis/Conformity.
  • Manages ERP Usage Decisions for Sanofi Geel batches.
  • Provides QP feedback during involvement meetings and escalation as needed.
  • Reviews deviations/change controls requiring QP involvement; approves retest plans.
  • Approves analytical batch abstracts and Drug Substance Specification Sheets.
  • Reviews Periodic Product Review and approves shipment of samples when required.
  • Approves use or destruction of reference samples and regulatory sample requests.

Skills

Quality systems
Biotech production
QA collaboration
Dutch language
English language

Education

Master of Industrial Pharmacy
Valid QP number

Job description

Sanofi Geel is seeking a QP Delegate (Location: Geel) to oversee quality and batch release activities. You will act as the primary QP contact for quality issues, review and approve batch release dossiers, and manage certificates of analysis/conformity.

Key responsibilities include QP governance, deviations/change controls with regulatory impact, and approvals of analytical specs for products. Fluent Dutch and English are essential; Master of Industrial Pharmacy and a valid QP number are required.

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