QC Specialist (m/f)

REFERENZNUMMER:

374333/11

IHRE AUFGABEN:

-Own the knowledge of microbiological concepts & strategies to guarantee compliance, sterility assurance and a state-of-the art microbiological quality for pharmaceutical drug products
-Subject Matter Expertise (SME) for low endotoxin recovery (LER) analytical studies in the frame of the production of and sterile drug products
-Responsible for the validation and execution of LER studies on manufactured drug products
-Evaluation of demasking methods and implementation of the validated demasking method into routine endotoxin testing of drug products to increase the microbial quality and sterility assurance
-Responsible for analytical, conceptual and strategic microbial projects relevant to his/her specific expertise
-Evaluation, validation and introduction of new microbiological test procedures incl. alternative methods
-Support the optimization and validation of analytical methods and equipment
-Preparation and introduction of necessary SOP’s
-Support method transfers from and to the laboratory
-Provides the necessary training and support to new associates joining this position
-Provide and assure the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for members of MS&T, QA, QC and PUs

IHRE QUALIFIKATIONEN:

-BSc. in Microbiology, Biology, Biotechnology or equivalent scientific degree, MSc. or equivalent experience is desirable
-Fluent in English and proficient in site local language

WEITERE QUALIFIKATIONEN:

Quality management employee