- In your role as a Subject Matter Expert (SME) for the transfer of parenteral products, you prepare product-specific risk assessments to evaluate the technical feasibility and implementation at the respective contract manufacturing organisation (CMO).
- You define Critical Material Attributes (CMAs), Critical Quality Attributes (CQAs), and the resulting Critical Process Parameters (CPPs) in accordance with relevant guidelines.
- You play a key role in the preparation of master documentation for product transfers, working closely with our international Regulatory Affairs department.
- You evaluate data and documentation generated during product transfers and derive the necessary GMP-compliant conclusions and corresponding actions.
- Your responsibilities also include supporting the investigation and handling of quality-related deviations during transfers in close collaboration with the Quality department.
- You coordinate commercialisation-related aspects of product transfers with the Supply and Sales department.
- In addition, you provide backup support for the administrative requirements of product transfers, such as purchase order creation and invoice processing, as well as the electronic filing and management of documentation.
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