Associate Quality Engineer Leiden

Associate Quality Engineer

The Company
Our client is one of the top multinational pharmaceutical companies globally whose goal is to help people be healthier by supporting better access and care in more places around the world and support good works and charities, better health, and education in protecting the environment and natural resources.

Role Description
We are seeking a skilled and detail-oriented Quality Engineer with expertise in CAPA (Corrective and Preventive Action), change controls, deviation management, complaint documentation, KPI (Key Performance Indicator) tracking, and driving process improvements. The ideal candidate will have a strong background in biotech, biochemistry, or process technology and a minimum of 2 years of experience in the biotech or biopharma industries.

Responsibilities

• Lead and participate in CAPA investigations, ensuring timely and effective resolution of quality issues.
• Manage change controls, ensuring compliance with regulatory requirements and internal procedures.
• Serve as a subject matter expert on deviation management, providing guidance to cross-functional teams.
• Document and investigate complaints, implementing corrective actions as necessary to prevent recurrence.
• Develop and track KPIs to measure the effectiveness of quality processes and drive continuous improvement.
• Lead initiatives to optimize quality systems and processes, identifying areas for enhancement and implementing solutions.

Requirements

• Bachelor’s or master’s degree in biotechnology, Biochemistry, Process Technology, or a related field.
• Minimum of 2 years of experience in quality engineering within the biotech or biopharma industries.
• Strong understanding of CAPA, change controls, deviation management, and complaint handling processes.
• Experience in leading process improvement initiatives and driving change within a regulated environment.
• Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.

Other Information
If you think this role is for you and you want to explore more of the possibilities, please contact Leri Salve Lapore and apply via the button below.