Quality Person In Plant

The job description outlines the role of a Quality Person In Plant at Legend Biotech in Ghent, Belgium. This role is crucial for providing quality oversight over the production of personalized cell therapies. It involves working within a team on a production shift schedule, including weekends and evenings, to support the 7/7 days cell processing.

The role involves:

• Ensuring quality oversight in plant.
• Performing periodic quality checks and audits.
• Reducing non-conformances and deviations.
• Reviewing process documentation.
• Collaborating with site personnel to resolve manufacturing issues.
• Supporting investigations of deviations, CAPAs, and change controls.
• Reviewing and approving manufacturing procedures and batch records.
• Supporting regulatory inspections and audits.
• Performing internal housekeeping audits.

Requirements:

• A Bachelor’s Degree in Science, Engineering, or equivalent technical discipline.
• Minimum of 2 years relevant work experience in an aseptic manufacturing facility.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Excellent attention to detail and ability to follow procedures.
• Strong organizational and teamwork skills.
• Good written and verbal communication skills.
• Proficiency in Dutch and technical English.

Role offers:

• Opportunity to work in cell therapy manufacturing.