Typical Accountabilities
Specific Responsibilities/Tasks
Establishment and maintenance of Quality Management System (A Certificate) of ADC products
Being responsible for establishing and maintaining the Quality Management System of ADC products that comply with the requirements of the drug regulatory authorities and ensuring regulatory compliance.Contract Production Supervision:Regularly evaluate QMS of the entrusted party (CMO) to ensure it continues to meet the standards stipulated in the contract and fulfil the obligations stipulated in the Quality Assurance Agreement (QAA) to ensure effective integration of QMS of both parties.Support GQA regular on-site inspection of the QMS of Contract Manufacturing Enterprise to ensure that it continues to comply with legal that personnel meeting the qualification requirements are stationed in the Contract Manufacturing Enterprise during the entrusted manufacturing of drugs and carry out on-site guid...