Oversee all analytical testing activities to ensure compliance with cGMP, GLP, ANVISA RDC, and other applicable regulatory requirements, ensuring data integrity, accuracy, and traceability throughout all operations, maintaining the laboratory in a state of inspection readiness.
- Ensure robust method transfer processes are in place and executed effectively, collaborating closely with R&D, manufacturing, and third-party contractors.
- Drive the timely release of analytical results within schedules while maintaining stringent quality standards.
- Manage the acquisition, qualification, calibration, and maintenance of all QC laboratory equipment and instrumentation.
- Oversee the entire process for chemicals, reagents, and reference standards management, from procurement to disposal, ensuring supply chain integrity and compliance.
- Establish and maintain robust quality systems within QC, including OOS/Deviation management, CAPA effectiveness, change control, ...