Oorspronkelijke vacature omschrijving:

• Audit Support: Participates in internal and external audits: conducts regular production walkthroughs to ensure compliance.

  
  

• Quality Event Management: Initiates, drafts, reviews, and closes quality events (deviations, CAPAs, change controls) within set timelines.

  
  

• Documentation Review: Manages and updates batch records, SOPs, and other GMP documents.

  
  

• Process Improvement: Recommends and implements improvements in production processes, planning, and training.

  
  

• Compliance Reporting: Alerts supervisor to any compliance issues and proposes solutions.
  
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• Bachelor degree Pharma, Biomedical, Cell and Gene therapy

  
  

• Minimum 1 year of work experience as a technical writer within pharmaceutical industry

  
  

• Minimum 1 year work experience with GMP

  
  

• Experience with planning, prioritization and scheduling skills

  
  

• Strong ability to interpret data and troubleshoot.