Your role

• You will give quality assurance oversight on (IQOQ / PQ…) protocols and reports
  
• You will help define and support the Validation Approach
  
• You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR)
  
• You will review CSV specific SOP’S and Templates
  
• You will perform risk assessments
  
• You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments, …)
  
• You will make sure that production practice are aligned with validation conclusion
  
• You will communicate to management about issues in the validation process
  
• You will attend project meetings
  
• You will provide QA oversight and approve deviation
  
• You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process
  
• You will define validation strategies through the change control process
  
• You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review, ….)
  
• You will ensure the correct application of the validation quality systems in the field and define an improvement plan as required
  
• You will support the production, QA and technical service teams in the implementation of validation activities
  
• You will work in close collaboration with production, engineering, maintenance, QC, QA…
  

Your profile

• Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains
  
• French or Dutch fluent and fluent in English
  
• A minimum relevant experience of 2 years in the (bio)pharmaceutical sector in a computer systems validation role
  
• Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus
  
• Good interpersonal relationship skills
  
• Problem solving and achievement oriented
  
• Be a good team player in order to succeed in each validation project
  
• Be able to use a risk-based approach for problem solving and prioritization of tasks
  

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