Working as Quality Assurance professional in clinical trials and for biotechnology sector, I am constantly participating in maintaining quality and improving processes with the strong focus on patients safety.
• Preparation and reviewing of documentation (including batch records)
• Participation in internal and external audits
• Verification of processes for compliance with
regulations and internal procedures
• Participating in change control, risk analysis and
deviations, including investigations and verifications of
CAPA in accordance with applicable procedures
• Participating in technology transfer
• Executing USP experiments according to planned
schedules and following quality standards
• Operation of bioreactor systems
• Maintaining assigned laboratory equipment up to
date and in operation state following internal
maintenance and service policies
• Troubleshooting and supporting process development/
close cooperation with other teams e.g. MS&T and
production departments
• Leading Cell Line Construction projects
• Reporting results to customers and presenting at
internal and customer meetings
• Execution of cell line construction and process
evaluation
• Trainer for cell culture manipulations, media, feeds
preparation and cryopreservation of cell banks
• 6S area inspections, routine health and safety checks
• Writing reports for customers.
• Sample reception, booking and labeling, preparing documentation (LIMS system)
• Water analysis and contamination testing
• Media preparation/ buffer preparation/calibrations/
checking and archiving laboratory records
• Retention samples coordination
• Scheduling and planning the daily work for team
members
• Meeting needs of terminally ill patients
• Completing forms, records, logs, following policies and
procedures