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