Lead IPC Method Transfers
The QC Laboratory Manager oversees the technical transfer of In-Process Control (IPC) analytical methods and IPC testing of Active Pharmaceutical Ingredients, intermediates, and cleaning samples. This role ensures compliance with regulatory requirements and drives continuous improvement initiatives.
* Project Planning: Lead the planning and execution of analytical method transfers for IPC testing, ensuring timely project completion and objectives are met.
* Liaison Point: Serve as the primary point of contact for all IPC technical transfer activities, facilitating communication between internal analytical teams, manufacturing sites, and external partners.
* METHOD DEVELOPMENT AND VALIDATION: Coordinate the development and validation of IPC analytical methods, including protocol design, execution, and documentation.
* Risk Assessment: Conduct risk assessments and troubleshooting activities to address IPC technical challenges and ensure the successful implementation of analytical methods.
* Document Generation: Generate and review technical documents, including IPC transfer protocols, reports, and standard operating procedures (SOPs), to support IPC method transfer activities.