Compliance Engineer

Antwerpen - Belgium - Life Sciences & Health Care - Pharmaceutical - Medical - Academic Master

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Are you the Compliance Engineer we are looking for?

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Feel free to contact

Elke Binst, Account manager

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About this role

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

About you

  • 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

What we offer

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

Summary

  • Publication: PUB292640
  • Location: Antwerpen
  • Market: Life Sciences & Health Care
  • Hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Master
  • Area of expertise: Medical
  • Closing date: Wednesday, March 10, 2021
Apply now

Feel free to contact

EB

Elke Binst

Account manager Brunel Belgium Mechelen

+32 (0)15 27 33 33

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