QC Specialist - Microbiological Quality Control (m/f)

REFERENZNUMMER:

337613/11

IHRE AUFGABEN:

-Support the microbiological qualification/validation activities within the New Solid Launch Facility (WST-222)
-Operate as a microbiological QC SPOC for all microbiological related activities within the NSLF
-Support microbiological quality control services for the qualification and the microbiological and physical/chemical monitoring of clean utilities
-Establishment and maintenance of the maintenance plans in SAP for an adequate biological, chemical/physical and microbiological testing of water and gases for pharmaceutical use, incl. drinking water and for the environmental monitoring
-Support method transfers from and to the laboratory
-Support the optimization and validation of analytical methods and equipment as well as cooperation on pharmacopoeial issues
-Support preparation of authority inspections and participate as a microbiological expert
-Cooperation with the team leaders QA and QC of the PU Solids/NSLF production departments or other quality assurance teams in order to optimize the quality of the processes and the manufactured products as well as to maintain compliance with authority requirements
-Support authoring and reviewing of SOPs, either microbiological QA/QC-SOPs or production-SOPs

IHRE QUALIFIKATIONEN:

-Completed studies at a technical university/academy in general or medical microbiology, biochemistry, pharmacy or equivalent
-Experience in biological/microbiological analytics or diagnostics including growth properties of micro-organisms and culture media preparation
-Very good English skills

WEITERE QUALIFIKATIONEN:

Quality manager