Compliance Engineer

PUB292640

About this role:

Does this vacancy match your profile?

Are you the Compliance Engineer we are looking for?

Don't hesitate and apply now! :-)

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

What you need to bring:

  • 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

Benefits:

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

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Elke Binst is happy to clarify anything about this vacancy. When reaching out, use this number:
PUB292640

Account manager

Elke Binst
Brunel Belgium Mechelen
e.binst@brunel.net

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