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Brunel

Compliance Engineer

Antwerpen - België - Industrie - Werktuigbouwkunde - Veiligheid, Gezondheid, Milieu & Kwaliteit - Academic Master
  • Brunel
  • Meerdere regio's
  • Onbepaalde duur, Voltijds
Staat 10 dagen op Jobat.be

Compliance Engineer

Does this vacancy match your profile?

Are you the Compliance Engineer we are looking for?

Don't hesitate and apply now! :-)

Functieomschrijving

Provide 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)
  • Evaluate calibration deviations and initiate, follow up on and document corrective actions to bring instruments back in compliant condition.
  • Preparation of intakes. (Sr only)
  • Update data in compliance follow-up tools ( eg Trackwise, . )
  • Closely work with client's engineers and plant representatives
  • Awareness of client's compliance procedures by following client's trainings

Profiel

  • 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.
  • Problem-Solving:A technical background is required , person must have feeling with the involved equipment : Dryers, Pumps , Powder units, piping , centrifuges, .
  • AccountabilityEach teammember must be aware that poor performance is directly affecting these KPI's , resulting in a malus or bonus.
  • Bachelor 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

Aanbod

We offer you an interesting project at one of our international clients.
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    Aanbod

    • Onbepaalde duur
    • Voltijds
    • Groepsverzekering
    • Maaltijdcheques
    • Individuele hospitalisatieverzekering
    • Hospitalisatieverzekering voor familie
    • Eco Cheque

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    • 14 december

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