Quality Assurance Specialist

Responsibilities:

Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates.
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 xqknzec 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