LIMS Validation Manager (m/f)

REFERENZNUMMER:

291343/1

IHRE AUFGABEN:

-Define, execute and monitor the global validation approach for the LIMS system implementation
-Ensure GxP compliance of the global LIMS system
-Create and approve the validation plan as well as key validation deliverables together with the global key users
-Support validation testing and approve test reports (integration test, user acceptance test, module test)
-Ensure that validation documentation is up-to-date and stored in the central system
-Support design and execution of data migration concept
-Provide quality assurance and regulatory support
-Advise involved functions in the change request process
-Train the LIMS GKUs in creating validated documents, e.g. URS, RA, test protocols

IHRE QUALIFIKATIONEN:

-Very good experience in Computer Validation System
-Experience with LIMS system
-In-depth experience in project management and quality processes
-Strong knowledge of cGMP
-Profound experience with work in a matrix organization
-Profound experience in pharmaceutical industry
-Business fluent English skills
-Willingness to travel (more than 50%)

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist