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CSV Lead

Contract
Brussels , BE
07.08.2024

Job Title:CSV Lead

Location: Brussels , BE

Employment Type: 

Contract

We are seeking an CSV Leadfor a strategic role to support internal compliance leads. The focus is on the strategic aspect rather than the SME level, meaning you will not be writing validation documents but will be involved in strategy development.
You will be part of the IT Compliance department, overseeing computerized system validation for both GxP and non-GxP systems throughout the entire validation lifecycle, including testing. 

Responsabilities:

  • Support in writing SOPs
  • Attend project meetings
  • Monitor compliance, KPIs, and deviations
  • Provide support on projects
  • Assist the team

Qualifications:

  • At least 5 years of relevant experience (preferred 10 years or more)
  • Seniority and autonomy in defining validation strategies
  • Extensive experience in validation processes, including knowledge of GAMP guidelines and Agile validation methodology
  • Strong understanding of process-oriented and regulatory guidelines
  • Experience in team leadership within this context
  • Focus on domains such as GCP, GPVP, and GLP (less emphasis on GMP)
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