QA Equipment Qualification Engineer

MindCapture; Belgique; Sur place; EUR 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture in Antwerp is hiring a Medior QA Equipment Qualification Engineer to join a GMP-regulated environment. You will oversee qualification activities for process and laboratory equipment, review qualification documents, support change controls and investigations, and help maintain inspection readiness.

Work with cross-functional partners to ensure compliant execution and timely project delivery, applying risk-based quality principles to equipment qualification, calibration, maintenance

Qualifications

• Experience with equipment qualification and risk-based methodologies.
• Pharmaceutical industry experience.
• Knowledge of GMP and regulatory guidelines.
• Strong focus on quality and practical problem-solving.

Responsabilités

• Provide QA oversight for equipment qualification activities.
• Review and approve user requirements, risk assessments, and qualification protocols.
• Lifecycle management of systems including calibration, maintenance and lifecycle processes.
• Assess deviations/non-conformances and support investigations with CAPA.
• Provide quality oversight for change projects throughout the system lifecycle.
• Ensure qualification activities meet applicable regulations and internal standards.
• Support regulatory inspections, customer audits and internal assessments.
• Maintain knowledge of regulations and best practices for qualification processes.
• Collaborate with cross-functional partners to achieve project objectives.
• Support remediation activities for legacy systems and qualification documentation.

Connaissances

Equipment qualification

Regulated environment

Quality mindset

Communication skills

English & Dutch

Formation

Pharmaceutical background

Description du poste

Jobs / QA Equipment Qualification Engineer

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

You will provide quality oversight across qualification and lifecycle activities for process equipment, laboratory equipment, utilities and controlled environments. The role focuses on reviewing qualification documentation, applying risk based quality principles, supporting change controls and investigations and maintaining inspection readiness. You will collaborate with stakeholders across different functions to ensure compliant execution while supporting project timelines and effective solutions.

Key responsibilities

• Qualification oversight: Provide QA support for equipment qualification activities and ensure appropriate risk assessment approaches are applied
• Documentation review: Review and approve user requirements, risk assessments, design qualification, installation qualification, operational qualification, performance qualification protocols, test scripts and reports
• Lifecycle management: Review procedures covering qualification, calibration, maintenance and lifecycle management of systems
• Deviation management: Assess deviations and non conformances, support investigations and ensure effective corrective and preventive actions
• Change control: Provide quality oversight for change projects throughout the complete system lifecycle
• Compliance: Ensure qualification activities meet applicable regulations, industry guidelines and internal quality standards
• Inspection readiness: Support regulatory inspections, customer audits and internal compliance assessments with qualification expertise
• Continuous improvement: Maintain knowledge of relevant regulations and industry practices to strengthen qualification processes
• Stakeholder collaboration: Work closely with cross functional partners to resolve challenges and achieve project objectives
• Legacy systems: Support remediation activities for existing systems and qualification documentation

Required competences & skills

• Experience: At least five years of relevant QA experience in a regulated environment
• Qualification expertise: Demonstrated experience with equipment qualification and risk based methodologies
• Pharmaceutical background: Strong experience within the pharmaceutical industry
• Quality mindset: Strong focus on quality, compliance and practical solutions
• Technical scope: Experience with process equipment, laboratory equipment, utilities or controlled environments
• Investigation skills: Experience with change controls, non conformances and investigations
• Communication: Strong communication skills with the ability to discuss complex or challenging topics constructively
• Collaboration: Ability to challenge stakeholders constructively while maintaining productive working relationships
• Languages: Fluent spoken and written English and Dutch
• Availability: Flexibility during summer and Christmas vacation periods
  

Quality & Compliance Antwerp 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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