Management of the microbiology laboratory, taking into account the pharmaceutical regulations and the BG guidelines for laboratory safety.
Interim management of the packaging laboratory
Organization and ensuring the proper execution of microbiological investigations
Conducting risk assessments in microbiological matters
Ensuring, defining and verifying environmental monitoring at the Neustadt plant
Assistance in ensuring, defining and verifying proper sampling at the Neustadt plant
Coordination of training and development plans
Support in organizing the examination of finished products, intermediate products, active ingredients, stability samples and packaging materials
Assistance with the control and monitoring of the qualification, calibration and maintenance of testing facilities and equipment, including equipment release.
Participation in the validation of methods and the introduction of new control procedures
Creation, updating and, if necessary, review of quality records, method specifications and SOPs in the aforementioned laboratory.
Handling deviations and OOX results, complaints and change requests
Representation of the laboratory supervisor qPCR, the laboratory supervisor chromatography and chemical/physical laboratory and the laboratory supervisor enzyme laboratory
Responsibilities
Management of the microbiology laboratory, taking into account the pharmaceutical regulations and the BG guidelines for laboratory safety.
Interim management of the packaging laboratory
Organization and ensuring the proper execution of microbiological investigations
Conducting risk assessments in microbiological matters
Ensuring, defining and verifying environmental monitoring at the Neustadt plant
Assistance in ensuring, defining and verifying proper sampling at the Neustadt plant
Coordination of training and development plans
Support in organizing the examination of finished products, intermediate products, active ingredients, stability samples and packaging materials
Assistance with the control and monitoring of the qualification, calibration and maintenance of testing facilities and equipment, including equipment release.
Participation in the validation of methods and the introduction of new control procedures
Creation, updating and, if necessary, review of quality records, method specifications and SOPs in the aforementioned laboratory.
Handling deviations and OOX results, complaints and change requests
Representation of the laboratory supervisor qPCR, the laboratory supervisor chromatography and chemical/physical laboratory and the laboratory supervisor enzyme laboratory
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