Found Description
Oversee all analytical testing activities to ensure compliance with c GMP, 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, and risk management. Provi...
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, and risk management. Provi...