Quality Control Scientific Expert

Responsibilities:

*Documentation of experiments and results according to procedures
*Evaluation of results
*Responsible for writing studyplans, SOP's/protocols in close consultation with the scientist
*Implementation of new techniques and assays
*Stay up to date on novel technologies related to the work area
*Communication with external parties
*Specific process-related responsibilities/accountabilities (PDVS): 1. Execute experiments according to predefined Study Plans
*Assay development/qualification/validation
*Stability/(Pre) Process Robustness/Comparability studies
*Characterization testing
*Matrix validation
*IQ/OQ/PQ, including writing IQ/OQ/PG Plan and Report for:
*Utilities, Rooms at rest, Rooms in operation, Cleaning Specific professional/technical requirements, Environmental Monitoring

Experience:

*Bachelor or Master level in Microbiology or related discipline.
*In depth knowledge of GMP microbiology laboratory testing and environmental monitoring testing.
*Expert knowledge of Microbial testing techniques used in aseptic manufacturing.
*Expertise in method development and method validation related to microbiological testing.
*Knowledge of biopharmaceutical manufacturing, especially related to the vaccines industry.
*Knowledge of regulatory aspects of microbiological activities.
*Knowledge of development and implementation of sampling plans for environmental and utilities controls.
*Language: English, preferably Swiss German.