QA Project Engineer MES — Healthcare GMP Specialist

MindCapture BV; Belgique; À distance; EUR 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture in Ghent seeks a Medior QA Project Engineer MES to oversee verification activities from planning to completion and ensure compliant timely delivery. You will review master batch records within the manufacturing execution system and collaborate with Quality, Operations, IT and project teams.

Ideal candidates have GMP knowledge and 3+ years in pharma, with strong analytical, communication and cross-functional collaboration skills.

Qualifications

• Bachelor or Master degree in bioengineering, pharmacy or another relevant technical or scientific field.
• At least three years of cross functional pharmaceutical industry experience.
• Sound knowledge of GMP requirements and pharmaceutical regulations.
• Practical experience with master batch records and quality within a GMP production environment.
• Experience reviewing batch record verification or qualification documentation is a plus.
• Experience with MES in production environments is a plus.
• Strong analytical and decision making capabilities with a solution oriented mindset.
• Strong communication skills with ability to align stakeholders.
• Ability to work independently while building cross functional relationships.

Responsabilités

• Quality oversight: Oversee verification activities according to procedures, priorities and timelines.
• Documentation review: Review checklists, design specs, testing strategies and verification protocols.
• Verification: Review executed protocols and supporting evidence through resolution.
• Project documentation: Review traceability matrices, qualification documentation and quality plans.
• Data integrity: Support master data, electronic batch records and MES elements.
• Compliance: Ensure deliverables meet GMP and internal requirements.
• Risk management: Identify risks, deviations and test observations.
• Continuous improvement: Contribute to improvements across digital Quality processes.
• Stakeholder alignment: Provide updates and elevate issues.
• Inspection readiness: Maintain inspection-ready documentation.

Connaissances

GMP knowledge

Analytical skills

Communication

Independent work

Cross-functional collaboration

Decision making

Formation

Bachelor or Master in bioengineering, pharmacy or related field

Outils

Manufacturing Execution Systems (MES)

Description du poste

MindCapture in Ghent seeks a Medior QA Project Engineer MES to oversee verification activities from planning to completion and ensure compliant timely delivery. You will review master batch records within the manufacturing execution system and collaborate with Quality, Operations, IT and project teams.

Ideal candidates have GMP knowledge and 3+ years in pharma, with strong analytical, communication and cross-functional collaboration skills.