As a QA Engineer you review batch abstracts to release products in accordance with approved specifications and procedures.
You monitor partner compliance through GxP documentation reviews and on-site visits.
You distribute relevant documentation for Regulatory, Validation, and Subject Matter Expert review.
You collaborate with multi-functional internal and external project teams to ensure compliance.
You address technical and quality issues and resolve scheduling and process-related conflicts.
You demonstrate an understanding of regulations related to the manufacturing of medicinal products (biologics).
You manage notification flows within quality systems between internal and external partners.
You monitor contractor performance to establish Key Performance Indicators (KPI's) and to report adverse trends.
Depending on experience, there is an opportunity to work abroad.
Requirements
Master’s degree and 3-5 years of experience in a cGxP or other regulated environment are required, with at least 3 years in a quality role. Experience in an international role is a plus.
Excellent communication and organizational skills are essential.
Proven ability to perform work with attention to detail and ensure high quality (i.e., right the first time).
Fluency in spoken and written English is necessary. Dutch is a plus.