• 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