• 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
• 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
Do you have valid Pharma license?
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Orphan Teb Pars
Orphan Teb Pars pharmaceutical company is active in registration, contract manufacturing and importation of pharma products in the fields of Hematology, Neurology, Infectious Diseases, Cardiology, Endocrinology, Nephrology, Rheumatology and Anesthesiology.
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