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EFOR
Quality Assurance SpecialistEFOR • Geel, Flemish Region, BE
Quality Assurance Specialist

Quality Assurance Specialist

EFOR • Geel, Flemish Region, BE
1 dag geleden
Functieomschrijving

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


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Quality Assurance Specialist • Geel, Flemish Region, BE

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