Global QA Lead: Serialization & 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

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