Compliance Engineer

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.