Carry out the necessary measures to select the local factories for technology transfer and under-license manufacturing process
Arrange technical and quality agreements with local and foreign contracting parties
Manage all stages of technology transfer and under-license manufacturing process
Plan, schedule and estimate the resources needed for technology transfer and under-license manufacturing process
Inventory management of under-license manufacturing site
Cooperate with the regulatory affairs & product quality department to manage recalls, returns, complaints, stability studies, PMQC studies, waste disposal, change management, etc.
Identify, evaluate, and select authorized raw materials suppliers
Periodic visits of under-license manufacturing sites.
Requirements:
Preferably a Pharmacist - Doctor of Pharmacy (Pharm.D.).
At least 5 years of experience in manufacturing in the pharmaceutical industry (preferably in technology transfer and under-license manufacturing).
Familiar with GXP principles.
Familiar with Quality Assurance in the pharmaceutical industry.
Familiar with the related local and international rules and regulations (Iran’s Food and Drug Administration, FDA, EU, ICH, etc.).
Familiar with technical documents in the pharmaceutical industry (CTD, CPP, COA, Proforma, Invoice, etc.).
Familiar with principles of project management.
Good communication, negotiation, and analytical skills.
Result-oriented, hardworking, motivated, team worker, and problem solver.