QA Specialist Serialization and Automation

MindCapture BV; Belgique; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

MindCapture Beerse seeks a QA Specialist Serialization and Automation to act as the global Quality representative for serialization and manufacturing automation initiatives. The role focuses on harmonising procedures, aligning with international regulatory requirements and defining Quality controls for automation projects.

On-site at Beerse, you will lead training, collaborate with Quality, IT, Regulatory Affairs, Operations and commercial stakeholders, and support change control and governance

Qualifications

• Eight+ years of Quality experience in pharma/biotech manufacturing.
• Three+ years of serialization or track-and-trace at global scale.
• Proven ability to write and implement global GxP procedures.
• Knowledge of EU/US/China traceability requirements.
• Strong understanding of serialization systems and Quality needs.
• Automation experience is a plus.
• Knowledge of data integrity principles is a plus.
• Experience with change control, risk assessment and governance.

Responsabilités

• Quality leadership: Act as primary Quality contact for regulatory and compliance matters.
• Global procedures: Develop consolidated serialization procedures and work instructions.
• Regulatory translation: Convert global requirements into practical Quality controls and site procedures.
• Procedure alignment: Ensure consistent implementation of global serialization requirements across sites.
• Training: Lead training and competency activities for Quality and operations teams.
• Automation support: Assess Quality impact of manufacturing automation integration activities.
• Quality requirements: Define documentation and Quality expectations as automation projects progress.
• Change management: Support change controls, risk assessments and procedural updates.
• Stakeholder alignment: Collaborate with Quality, IT, Regulatory Affairs, Operations and commercial stakeholders.

Connaissances

Quality leadership

Serialization systems

GxP procedures

Regulatory knowledge

Automation integration

Data integrity

Change control

Risk assessment

Stakeholder management

Formation

Bachelor's degree in pharmacy or life sciences

Advanced degree (plus)

Description du poste

Jobs / QA Specialist Serialization and Automation

QA Specialist Serialization and Automation

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 Specialist Serialization and Automation, you will act as the global Quality representative for cross functional initiatives involving serialization systems and manufacturing automation. Your primary focus will be developing and deploying one harmonised set of global serialization procedures while ensuring alignment with international regulatory requirements. You will also assess Quality impact and define requirements for a new manufacturing automation integration approach.

Key responsibilities

• Quality leadership: Act as primary Quality contact for regulatory and compliance matters.
• Global procedures: Develop consolidated serialization procedures and work instructions.
• Regulatory translation: Convert global requirements into practical Quality controls and site procedures.
• Procedure alignment: Ensure consistent implementation of global serialization requirements across sites.
• Training: Lead training and competency activities for Quality and operations teams.
• Automation support: Assess Quality impact of manufacturing automation integration activities.
• Quality requirements: Define documentation and Quality expectations as automation projects progress.
• Change management: Support change controls, risk assessments and procedural updates.
• Stakeholder alignment: Collaborate with Quality, IT, Regulatory Affairs, Operations and commercial stakeholders.

Required competences & skills

• Experience: At least eight years of Quality experience within pharmaceutical or biotechnology manufacturing.
• Serialization: At least three years of experience with serialization or track and trace initiatives at global scale.
• SOP expertise: Strong experience writing and implementing global GxP procedures.
• Regulatory knowledge: Practical knowledge of European, United States and Chinese traceability requirements.
• Technical knowledge: Strong understanding of serialization systems and related Quality requirements.
• Automation: Experience with manufacturing automation is a plus.
• Data integrity: Knowledge of data integrity principles is a plus.
• Quality systems: Strong skills in change control, risk assessment and procedural governance.
• Stakeholder management: Excellent influencing and collaboration skills across global functions.
• Education: Bachelor degree in pharmacy, life sciences, engineering or a comparable field. An advanced degree is a plus.
  

Quality & Compliance Beerse Senior 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.

Job Contact – Talent & Business Team

Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.

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