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Quality Systems Specialist


The company
Our multinational client is a biotechnology company based in North Holland. They are on the aspiring mission to find the cure to cancer, by working on making cancer immunotherapy products, and focusing on their special therapies.

Role description
As a Quality Systems Specialist, you will be responsible for the Quality Systems of our client in a broad sense. You will make sure of the maintenance and training for cross site procedures like Change Control, Deviation, CAPA management and Internal Audits. You will identify risks, support regulatory inspections, work on metric management, make sure of site compliance, and work towards improving processes according to regulatory guidelines and company policies.

Responsibilities
Make sure that the Quality Systems are compliant with regulations and quality policies.
Ensure the management, maintenance and training for cross site procedures like Change Control, Deviation, CAPA management, regulatory inspections and audits.
Review, approve cGMP documents, and make sure of their maintenance.
Maintain the company’s Exception Management system, review and approve proposed changes to systems and procedures.
Assist product development projects and technical transfer activities with compliance guidance.
Work on metric management and work towards the continuous improvement of quality systems.

Requirements
Bachelor’s degree in Chemistry/Microbiology/Engineering or similar.
Minimum 3-5 years of Quality Assurance experience in GMP environment.
Experience with Change Control, CAPA, Internal Audits, Deviations and other ICHQ10 quality systems.
Strong knowledge of regulatory requirements (EU GMPs and ICHQ10), quality systems (Veeva Vault), Trackwise Enterprise Quality Management System (EQMS), MS Office tools, and exception management systems.
Experience with aseptic manufacturing processes.
Familiarity with advanced therapy medicinal products (ATMP), and having an ASQ/Black Belt/Green Belt certifications is a plus!

Other information
Are you interested in this or another role? Please do not hesitate to contact me by applying to this position.