Technology Transfer Manager

Rougine Darou Tehran

Posted a month ago

Job Description

  • 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.
  • Average knowledge of Microsoft Office.
  • Good command of English, both written and spoken.

Employment Type

  • Full Time

Seniority

Details

Employment type

  • Full Time

Seniority

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