QA Project Engineer MES: Master Batch Records & GMP

Pauwels Consulting

Beerse

Sur place

EUR 70 000 - 95 000

Plein temps

Il y a 3 jours

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Résumé du poste

Our client, a leading pharmaceutical organization, seeks a QA Project Engineer MES to join their digital quality team. You will oversee quality deliverables to ensure compliant manufacturing through advanced electronic systems.

Key duties include reviewing MBRs, checklists, and testing strategies; ensuring traceability, PQs, and inspection readiness; supporting data integrity of MES elements; identifying risks and CAPAs; ensuring all deliverables meet GMP.

Qualifications

Bachelor or Master in bio-engineering, pharmacy, or a relevant scientific field.
3+ years cross-functional pharmaceutical experience.
Solid knowledge of cGMP requirements and pharmaceutical regulations.
Hands-on QA and MBR in GMP production environment.
Analytical with solution-oriented mindset.

Responsabilités

Provide QA oversight of MBR verification activities in line with procedures and timelines.
Review MBR checklists, design docs and testing strategies for electronic master batch records.
Review executed verification protocols and supporting evidence, ensuring all comments are resolved.
Review traceability matrices, PQ documentation, and project quality plans for inspection readiness.
Support QA and data-integrity oversight of MES elements and electronic batch records.
Confirm that all deliverables meet GMP and internal procedural requirements.
Identify and address risks, deviations and CAPAs throughout the project lifecycle.