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GMP Change Koordinator (M/W/D)
Aufgaben:
Compiling information relevant to the change request
Independent preparation of change requests and their implementation strategy, some of which are highly complex and detailed
Preliminary discussion of the contents of the change request and the implementation strategy with relevant departments
Entering the requests into the eQMS (currently “Trackwise”) with independent definition of the review team
Consolidating the actions required for the changes and coordinating their implementation (coordination of tasks across multiple departments)
Providing technical support for the implementation of the changes and coordinating execution across all project stages (e.g., technical implementation, qualification, validation, registration) until go-live
Regular status checks of change requests until final completion and preparation of regular status reports
Qualifikation:
Degree in engineering or equivalent
Minimum of 10 years’ experience in biotech/pharmaceutical
Experience in Aseptic Filling is an advantage
Previous experience with GMP Change Management and eQMS (“Trackwise”) is an advantage
English fluent
Rahmendaten:
Start: asap
Dauer: 2 Jahre
Auslastung: 37,5h die Woche
Einsatzort: Marburg
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