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Qualification Engineer

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Sophie Steels
Recruiter



Sophie Steels
Recruiter


Job description

In this position you will be responsible for carrying out work necessary for the qualification of GMP materials, services and suppliers, including investigating and solving qualification related problems and writing documentation for new and /or existing materials, services and suppliers, according to predefined procedures and system standards, in order to guarantee compliance with company standards and CGMP regulations.


Main responsibilities:

  • Determining the qualification approach for new and changed materials, services and suppliers, including changes, taking into account compendial and other regulatory requirements
  • Evaluating the qualification results
  • Execution and management of materials, services and suppliers trending and responsible for defining, executing and following up on corrective actions
  • Execution and follow-up of material and supplier certification activities and translation into specification documents and associated status management
  • Management of extractable/leachable studies and reports
  • Management of contracts with the supplier: business agreements, quality agreements, specification agreements and quality requirements in business agreements
  • Management (formulation, follow-up, handling) of non-conformities and complaints
  • Drafting, executing, approving, implementing and revising qualification procedures – and documents (protocols, reports, ...)
  • Supporting internal and external audits
  • Reporting and following up on deviations
  • Study of professional literature and current affairs
  • Follow up on changes in own domain and communicate them to the relevant functions
  • Provide training of procedures and methods
  • Participate in improvement initiatives and provide qualification support within projects


Profile

  • Master in a scientific direction, or equivalent through experience
  • Min. 3-5 years relevant experience
  • Knowledge of cGMP in a regulated environment
  • Knowledge of compendial requirements and extractable/leachable requirements is a plus
  • Knowledge of quality management systems
  • You are a go-getter with strong analytical and problem-solving abilities
  • You are result-oriented, flexible and work independently within the set objectives
  • You have good social and communication skills and you speak Dutch and English fluently


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