Implement and maintain Quality Systems including validation, change control, batch record review, and batch release for new and existing products
Review, prepare, and approve GMP documentation such as validation reviews, method transfer protocols, MES master batch records, material master changes, and change controls
Perform batch record review and prepare release documentation for raw materials, intermediates, and bulk products
Act as deputy process owner and subject matter expert for raw material release and WCB/DS/DPC release processes
Ensure quality systems are compliant, effective, and continuously optimized across the organization
Serve as a QA representative and subject matter expert during internal and external audits and regulatory inspections
Deputize for the QA Manager as required, including approval of QA documentation and oversight of key quality processes

Bachelor's degree or higher in Biochemistry, Biology, Pharmacy, or a related scientific discipline
Minimum of 2 years (MSc) or 4 years (BSc) experience in Quality or regulated supply chain operations
Strong knowledge of biotechnological or pharmaceutical manufacturing and global regulatory guidelines (cGMP, ICH, FDA, EMA)
Proven analytical, problem-solving, and risk-based decision-making skills with high attention to detail
Ability to work independently, prioritize effectively, and manage complex or conflicting stakeholder requirements
Strong communication, influence, and collaboration skills in cross-functional environments
Fluent in written and spoken English; knowledge of Dutch and experience in vaccines are considered a plus.

Quality Assurance Analyst

Key skills