QA Validation

Als onafhankelijk en toonaangevend technisch consultancy bureau, leveren we sinds 1991 technische expertise voor uiteenlopende projecten in de industrie, bouw en telecom. Voor een grote klant actief in de biofarmaceutische industrie zoeken we een QA Validator (regio Brussel).


Function

  • Coordinator QA validation (MPU LVV – bulk/formulation activities) :
  • Raise and maintains the status of quality in the organization
  • Develops, assures and maintains the quality of the product and processs.
  • Ensure QA oversight of all validation activities


Key Responsibilities

  • Ensure quality oversight of all validations activities (IOQ/PQ, …)
  • Ensure deviations and change controls are reviewed and handled in timely manner
  • Ensure critical topics are adequately and timely escalated to higher management
  • Represents QA in all validation meetings related to the area of responsibility
  • Performs internal audits, shopfloor, gemba’s and effectiveness check
  • Performs Risk assessment, GAP analysis, periodic review, validation plan and validation summary reports
  • Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirement
  • Understands validation/technical problems and evaluates their potential impact on product quality. Escalates complex problems to N+1

Profile

  • Scientific university degree (pharmacist, Engeneer or equivalent)
  • Minimum 2 years of experience in a pharmaceutical/BIO/Medical device environment or equivalent
  • Knowledge of GMP regulated environment, process/equipment validation and aseptic environment
  • Good knowledge of English

Offer

  • Een competitief salaris aangevuld met een brede waaier van extralegale voordelen (afhankelijk van contracttype en voorkeur).
  • Tewerkstelling bij een stabiele en gevestigde speler (meer dan 20 jaar) in de consultancywereld.
  • Een werkomgeving waar de focus ligt op eenieders sterke eigenschappen en de verdere verbetering daarvan.
  • Details

    Pharmaceutical
    Validation engineer

    Brussel
    2017-01-03
    Vast / Tijdelijk

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