About You
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Are you the Compliance Engineer we are looking for?
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Your responsibilities
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
Your profile
- 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
Our offer
We offer you an interesting project at one of our international clients.
