QA Project Engineer MES

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

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

As QA Project Engineer MES, you will oversee assigned Quality deliverables from planning through completion. Your primary focus will be reviewing verification documentation for electronic master batch records within the manufacturing execution system. You will collaborate across Quality, Operations, IT and project functions to ensure compliant and timely delivery.

Key responsibilities

• Quality oversight: Oversee verification activities according to approved procedures, priorities and timelines.
• Documentation review: Review checklists, design specifications, testing strategies and verification protocols.
• Verification: Review executed protocols and supporting evidence while following comments through resolution.
• Project documentation: Review traceability matrices, qualification documentation, quality plans, summary reports and implementation documentation.
• Data integrity: Support Quality oversight of master data, electronic batch records and manufacturing system elements.
• Compliance: Confirm deliverables meet GMP, data integrity and internal procedural requirements.
• Risk management: Identify and follow up risks, deviations, test observations and associated actions.
• Continuous improvement: Contribute to improvements across digital Quality processes and ways of working.
• Stakeholder alignment: Provide clear updates and elevate issues appropriately.
• Inspection readiness: Maintain complete, accurate and inspection ready documentation.

Required competences & skills

• Education: Bachelor or master degree in bioengineering, pharmacy or another relevant technical or scientific field.
• Industry experience: At least three years of cross functional pharmaceutical industry experience.
• GMP knowledge: Sound knowledge of current GMP requirements and relevant pharmaceutical regulations.
• Batch records: Practical experience with master batch records and Quality within a GMP production environment.
• Verification experience: Experience reviewing batch record verification or qualification documentation is a plus.
• Manufacturing systems: Experience with manufacturing execution systems in production environments is a plus.
• Analytical skills: Strong analytical and decision making capabilities with a solution oriented mindset.
• Communication: Strong communication skills with the ability to align different stakeholders.
• Independence: Ability to work independently while building effective cross functional relationships.

Quality & Compliance Ghent Medior At MindCapture as consultant

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

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We know timing is everything. If you don’t see a role that fits you right now, we still want to hear from you. Our consultants are always looking for talent, sometimes before the job even goes live.