This position will be covering Egypt, Iran, Libya, Tunisia, Algeria, & Morocco.French Language is a must and/or experience in Maghreb countries & Egypt
- Participate as a core team member in the International Expansion product/ country launch teams and product licensing efforts assisting in the liaison activities between Quality and all other key stake holders and/or partner companies.
- Collaborate with GRAAS in the identification of specific requirements for new product introduction.
- Co-ordinate transfer of analytical methods to specified country laboratories.
- Perform technical assessments/ audits of partner laboratories, warehouses and packaging facilities.
- Negotiate and facilitate the development of Quality Agreements.
- Develop the required quality systems necessary for the effective management of business partnerships in compliance with Amgen and regulatory requirements.
- Participate in the development of new product/country strategic plans and participate in the execution of applicable tasks to successfully accomplish project goals.
- Establish the Quality process for the on-going management of business relationships with partner companies in specified regions and countries. Assist with the execution of Amgen responsibilities as established through Quality Agreements and applicable regulatory and Amgen requirements.
- Develop reports and provide the necessary communications throughout the organizations as required to ensure effective
- information sharing.
- Appointed qualified person “ responsible pharmacist” for quality of Amgen and support Amgen in all quality matters related to Amgen’s products imported and distributed in relevant country and provide the necessary activities of an appointed qualified person as defined in the applicable laws and regulations of relevant country
- As the appointed qualified person shall be the primary contact for the Ministry of Health and any other governmental agencies handling quality matters. He/She is authorized to represent Amgen in all matters related to the Ministry of Health and any other governmental agencies handling quality matters.
