Quality Assurance Specialist

Responsibilities:

• Drafting and reviewing quality documentation within the scope of the project (project notes, quality plans, etc.)
• Reviewing and approving electronic master batch records in MES Pas-X
• Preparing and reviewing project documentation (e.g., procedures, risk assessments) with a focus on deviation prevention (DPP) and human error prevention (HEP)
• Ensuring compliance with SOPs, global standards, regulations, and product registration (filing) regarding clinical and commercial manufacturing
• Supporting cross-departmental collaborations
• Knowing when to escalate issues to the supervisor/manager

Required Skills & Qualifications:

• Master's degree in a scientific discipline or equivalent experience
• Knowledge and interpretation of cGMP in a regulated environment
• Experience with electronic batch records and related digital systems
• Knowledge and experience with quality processes and quality assurance
• Excellent accuracy and attention to detail
• Independence and a strong sense of responsibility
• An enthusiastic team player with strong communication skills
• Good writing skills
• Good command of the English language
• Fluent in Dutch