Dipl.-Ing. Ulrike Marder

Global subject matter expert on Quality Risk Management (ICH Q9) for the MSD Animal Health Sites. Responsible Quality Function for Capital Projects at the site (e.g. reconstruction, product transfer) Support inspections from authorities at the site, performing internal inspections

- Defining the Quality Risk Management Approach for MSD Animal Health Sites, Roll-out to the sites and leaging the QRM Community of Practice - Coaching the production team in problem solving and trouble shooting - Project for process improvements and deviation reduction Processing Deviations and complaints related with the manufacturing area

- Redefining Product Quality Reviews with statistical trending, process capability and control limits, overarching trend analysis - Redefining validation activities at the site: sterilization processes, cleaning validation and product validation - Ensurance of the qualified and validated state of processes and equipment in the manufacturing area - Subject Matter Expert for sterilization processes (dry heat, moisture heat, gamma sterilization, filtration), process validation and product quality reviews

- Processing deviations, change control and follow-up of CAPAs within production - root-cause analysis, problem solving, trouble shooting and definition of actions and strategys to achieve sustainable and effective solutions - compilation of risk assessments - statistical evaluations for process capability and process robustness - projects on process improvements in the manufacturing area

- Development and evaluation of statistical experimental designs - Design Space Definition based on statistical evaluations for new products and compilation of the development report acc. to ICH Q8 - Operational Project Lead: Supervision of pharm.development projects - Establishment and improvement of an in-vitro model with CaCo2 cells to determine permeation of APIs through gastro cells - Compilation of analytical validation reports for regulatory submission