The successful candidate will be accountable for;

  • Providing compliance (validation/qualification) support for GMP and EHS critical changes to production systems and facilities and provide support to ensure these systems remain in a GMP compliant state
  • Changes initiated by production or maintenance
  • Changes initiated by project engineering groups (MAM , E&PS )
  • Periodic reviews on the system’s documentation to ensure these systems remain qualified (3year period)
  • Evaluating calibration deviations and initiate, follow up on and document corrective actions to bring instruments back in compliant condition.
  • Batchelor or Master degree
  • Approximately 1 to 5 years of experience in pharmaceutical industry in qualification /compliance activities
  • Teamplayer
  • Dutch: native language
  • English: fluent in reading – good in writing
  • Committed to this role for at least 2 years
  • Knowledge of systems as SAP , Trackwise, E-stream , Truvault is a plus
  • A technical background is required, working experience with: Dryers, Pumps , Powder units, Piping and centrifuges
  • Needs to have sufficient knowledge of equipment qualification on GMP systems for production of API ‘s .
  • Knowledge of supporting data systems such as Trackwise and TruVault are advisory.