QA Project Engineer MES

Pauwels Consulting; Beerse; Sur place; EUR 70 000 - 95 000; Plein temps

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.

Connaissances

Pharma experience

cGMP knowledge

QA in MES

Documentation review

Formation

Bachelor or Master in bio-engineering/pharmacy

Outils

PAS-X

Opstracker

Description du poste

Our client, a leading pharmaceutical organization focused on innovative therapies, is seeking a QA Project Engineer MES to join their digital quality team. This role is responsible for overseeing quality deliverables to ensure compliant manufacturing through advanced electronic systems.

• Provide QA oversight of MBR verification activities in alignment with approved procedures and timelines.
• Review MBR checklists, design documentation specifications, and testing strategies for electronic master batch records.
• Review executed verification protocols and supporting evidence, ensuring resolution of all comments.
• Review traceability matrices, PQ documentation, and project quality plans to ensure inspection readiness.
• Support quality and data-integrity oversight of MES elements and electronic batch records.
• Confirm that all deliverables meet GMP and internal procedural requirements.
• Identify and follow up on risks, deviations, and corrective actions throughout the project lifecycle.

• You possess a Bachelor or Master degree in bio-engineering, pharmacy, or a relevant scientific field.
• You bring 3+ years of cross-functional experience within the pharmaceutical industry.
• You have sound knowledge of cGMP requirements and relevant pharmaceutical regulations.
• You possess hands-on experience with QA and master batch records in a GMP production environment.
• You're analytical and communicative with a practical, solution-oriented mindset.

Nice to Haves

• Experience reviewing MBR verification or qualification documentation.
• Practical experience with MES systems such as PAS-X or Opstracker.