Senior Scientist Digital Quality Control

As a Senior Scientist Digital Quality Control, you will play a key role in bringing our global QC digitalization strategy to life. You will collaborate with QC teams worldwide to implement a global Laboratory Execution System (LES), enabling the transition from paper-based laboratory documentation to digital method workflows. As part of a global QC team, you will create and verify digital method workflows, maintain global process documentation, and support implementation activities at our sites in Australia, Germany, Switzerland, and the United States. Responsibilities: Create digital method workflows in the BIOVIA ONE Lab Laboratory Execution System based on analytical method SOPs and process maps structured according to ISA-88 principles. Create and execute test cases to verify digital method workflows. Manage the lifecycle of digital method workflows, including master and dynamic data management, as a Business Administrator for BIOVIA ONE Lab. Develop User Requirements Specifications (URS) for laboratory instrument interfaces. Maintain global process documents related to the QC Laboratory Execution System. Support QC business process standardization and global data integrity initiatives related to laboratory automation and analytical instrumentation . Qualifications: Education University degree in a relevant scientific discipline (e.g., Biology, Chemistry, Microbiology, or a related field). Experience 3-5 years of experience in a pharmaceutical GMP testing environment, including the use of a variety of analytical instruments, instrument lifecycle management activities, and data integrity practices. At least 2 years of experience working with laboratory automation systems in a QC or R&D environment. Experience with BIOVIA ONE Lab or a comparable Laboratory Execution System is considered an advantage. Knowledge of GMP computerized system regulations and industry guidance, including GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles, is desira