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Senior QA Expert
Job ID: #
QA321
Description
As a Senior QA Expert, you will hold the ultimate administrative responsibility for preparing and issuing quality-related documentation and certificates applicable to the final product. You will address quality issues and manage quality-related projects within the organization. Additionally, you will conduct internal and external (customer) audits and follow up on and qualify suppliers.
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Requirements
Bachelor’s - or Master’s degree in engineering, science, or a related technical field (e.g., chemical or mechanical engineering), or an equivalent combination of education and experience.
Experience in the pharmaceutical sector is a plus.
Solid knowledge of ISO standards 9001, 14644, 11737. Knowledge of ISO 13485 is a plus.
At least 5 years of experience with ISO and GMP standards/certification/audits.
At least 5 years of experience in QA/QC roles within a Life Sciences environment is preferred.
Background in microbiology is a plus.
Experience with sterility programs is a plus.
High proficiency in Dutch and English. German and/or French is a plus.
Key Responsibilities
Maintain customer contact regarding quality and compliance.
Conduct internal and external audits.
Lead customer audits.
Assist with complaints and deviations.
Perform final quality inspections and prepare related documentation and certificates.
Keep supplier qualifications up to date.
Manage the Quality Management System (QMS) and act as the primary point of contact.
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