Career Category

Job Description

IDQ Director/ Responsible Pharmacist France shall ensure that quality system is implemented and maintained to ensure:

• Guarantee the compliance of the opening and maintenance of the “Exploitant” establishment status ;
• Organizing and overseeing all pharmaceutical operations of the Amgen S.A.S.: manufacturing, promotion (advertising and salesforce training), medical information, Pharmacovigilance, batch follow up and recall, distribution, importation and exportation of medicines, object or item and storage if needed
• Ensure that appropriate standards of GDP are maintained for their own premises Amgen S.A.S. and contracted storage premises
• Medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP/GMP;
• Management responsibilities are clearly specified;
• Products are delivered to the right recipients within a satisfactory time period;
• Records are made contemporaneously;
• Deviations from established procedures are documented and investigated;
• Appropriate corrective and preventive actions are taken to correct deviations and prevent them in line with the principles of quality risk management.
• Management of the Quality team of Amgen SAS