Quality Systems Engineer – GMP & Compliance

SIRE® Life Sciences ?; Leiden; On-site; EUR 55,000 - 75,000; Full time

Job summary

SIRE Life Sciences is seeking a Quality Engineer to provide quality systems and compliance support across manufacturing operations and external manufacturing partners. You will oversee quality performance, audits and process improvement activities, and address complex product and manufacturing issues to ensure compliance with GMP and ISO standards.

The role involves supporting quality systems, CAPA, supplier quality monitoring and performance reporting to drive continuous improvement in a GMP

Qualifications

• Experience in Quality Engineering or Quality Systems within a GMP manufacturing environment.
• Strong knowledge of GMP, ISO standards and manufacturing quality systems.
• Experience with quality audits, compliance assessments and process improvement.
• Knowledge of complaint handling, defect investigation and corrective and preventive actions (CAPA).
• Experience monitoring supplier or contract manufacturer quality performance.
• Ability to analyse quality metrics and translate findings into improvement actions.
• Strong technical problem-solving and analytical skills.
• Experience supporting manufacturing processes and/or technology transfers is advantageous.

Responsibilities

• Support the design, implementation and maintenance of quality systems and manufacturing processes.
• Assess compliance with GMP, ISO standards and Equipment Engineering Systems (EES) requirements.
• Oversee quality system audits and identify areas requiring corrective action or improvement.
• Investigate and resolve product and process complaints, defects and quality issues.
• Monitor contract manufacturer performance through quality metrics and management reviews.
• Establish and maintain measurement systems to evaluate quality and reliability performance.
• Identify, contain, correct and prevent product and process defects.
• Prepare and present quality performance reports and improvement recommendations to management.
• Provide technical quality support for complex manufacturing processes being transferred to other facilities.

Job description

SIRE Life Sciences is seeking a Quality Engineer to provide quality systems and compliance support across manufacturing operations and external manufacturing partners. You will oversee quality performance, audits and process improvement activities, and address complex product and manufacturing issues to ensure compliance with GMP and ISO standards.

The role involves supporting quality systems, CAPA, supplier quality monitoring and performance reporting to drive continuous improvement in a GMP