Worley | Belgium, Antwerp
The successful candidate will be accountable for;
- Providing 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)
- Evaluating calibration deviations and initiate, follow up on and document corrective actions to bring instruments back in compliant condition.
- Batchelor or Master degree
- Approximately 1 to 5 years of experience in pharmaceutical industry in qualification /compliance activities
- 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
- A technical background is required, working experience with: Dryers, Pumps , Powder units, Piping and centrifuges
- 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.