Quality Assurance Specialist (Senior Level)

Our client is a leading organization in the pharmaceutical industry, dedicated to ensuring the highest standards of product quality and compliance. They operate within a heavily regulated environment, committed to delivering safe and effective medicines to the market. We are seeking an experienced Quality Assurance Specialist to oversee the release of pharmaceutical products, ensuring all are compliant with applicable laws, regulations, and internal standards.

This key role involves inspecting, reviewing, and authorizing product documentation, managing quality investigations, and supporting regulatory inspections.

Responsibilities include: reviewing and approving master documents and specifications to support product release; initiating and evaluating quality investigations, including deviations, to determine release or rejection, and implementing improvement proposals; ensuring timely completion of deviation and investigation reports; leading quality improvement initiatives to control production risks; authorizing ongoing stability studies and Product Quality Reviews; preparing for and overseeing inspections by government agencies and customers; participating in self-inspections across production, laboratory, storage, and distribution areas; supporting and coordinating handling of complaints, root cause analysis, and implementation of corrective actions; managing product recalls and stock blockage proposals; investigating and documenting deviations and complaints thoroughly; developing and maintaining relationships with external partners related to quality oversight; participating in technology transfer activities and contributing to process improvements; and providing functional leadership to QA team members, including organizing work, implementing structured procedures, and contributing to staffing and training decisions.

Requirements include a degree in pharmacy, chemistry, biology, or a related field (per EU Directive 2001/83/EC); extensive experience with aseptic manufacturing processes (preferably over 5 years); knowledge of lyophilization and visual inspection processes is a plus; familiarity with automated pharmaceutical processes; strong understanding of EU and US pharmaceutical laws and regulations; and proficiency in analytical methods. The position is located in Haarlem, Netherlands, with a start date of 9/17/2026, and is a temporary assignment.