QA Validation Consultant Life Sciences (Wallonia)
Brussels, BE
4 dagen geleden

Your role

  • 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),
  • You will write Validation documents (protocols, reports, SOPs, Critical Impact Assessments, )
  • You will manage deviations,
  • You will coordinate and execute validation (IQ, OQ, PQ) tests,
  • You will perform risk assessments,
  • You will work in close collaboration with production, engineering, maintenance, QC, QA
  • You will ensure handover with final users,
  • You will ensure QA oversight in validation activities (IQ / OQ / PQ ),
  • You will ensure timely escalation to management of critical issues during validation,
  • You will define the validation strategies in accordance with the regulatory requirements,
  • You will attend all project meetings as (QA) validation representative.
  • Your profile

  • Master degree in engineering or related scientific domains,
  • Native level of French or Dutch and fluent in English,
  • At least 2 years of relevant experience in Validation in a GMP environment is mandatory,
  • Knowledge of management (project / team management),
  • 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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