Validation Supervisor (m/f)

REFERENZNUMMER:

321211/11

IHRE AUFGABEN:

-Coordination and supervision of Performance qualification activities and Process Validation activities on site at CMO
-Review and support development of the qualification and validation documentation
-Ensure the activities are executed according to the companies standards
-Tracking qualification and validation timeline and alignment with overall project plan, timely reporting of issues to the team
-PQ on rooms and utilities: HVAC & clean rooms, SCADA, sterile gases (nitrogen, compressed air), deep freezing rooms and cold rooms
-Process Implementation and Validation: freeze-thaw cycle implementation, freeze drying cycle

implementation, aseptic process validation – media-fill, sterile drug product manufacturing process validation, visual inspection process for media-fill vials, visual inspection process for lyophilized product

IHRE QUALIFIKATIONEN:

-Experience in qualification of utilities and equipment for sterile drug product manufacturing
-Experience in process validation for sterile drug product manufacturing
-Good GMP knowledge, knowledge of international standards for qualification, process

validation, practical experience in risk management, change control management, deviations management, environmental monitoring -Ability to organize and work with people on various levels at CMO site
-Fluency in English, Russian of advantage

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist