Responsible Pharmacist (Regulatory) Nikan Pharmed

  • Full Time

  • Tehran

      -   Tehran

Posted 5 months ago

Job Description

- Support all Regulatory Affairs activities in order to achieve and maintain registrations in compliance with all national and regional Regulatory and legal obligations - Effectively manages priorities in order to implement corrective and preventive actions - Appropriately applies principles of continuous improvement. - Annual product reviews and review of stability reports for compliance with Food and Drug Regulations - Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals - Timely approval of incoming batches, batch inspection and release according to SOPs - liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations

Requirements

- Pharmacist (Pharm D.) with valid Pharma license - 3 plus years’ relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs - Experience with GMP inspections and third party audits - Understanding of pharmaceutical policies and rules - Solid computer skills, using MS Office • Fluency in English language especially in writing