GMP Change Koordinator (m/f/d)

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

Start : asap

Dauer : 2 Jahre

Auslastung : 37,5h die Woche

Einsatzort : Marburg