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 representativesAwareness of client's compliance procedures by following client's trainingsNeeds 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 activitiesTeamplayer Dutch : native languageEnglish : fluent in reading - good in writingCommitted to this role for at least 2 yearsKnowledge of systems as SAP , Trackwise, E-stream, Truvault is a plus