Job Description
- Registration of Biopharma products in Food and Drug Organization (Iran)
- To ensure that, drug products, is manufactured and tested in accordance with laws of Food and Drug Organization and cGMP
- Update the company regarding any changes in regulation of Food and Drug Organization (Iran)
- Preparation and supervision of secondary packaging material artwork
- Review of the Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR)
- Release of API and finished products.
- Audit of suppliers.
- Handling of Complains.
- Handling of Recall.
- Regulatory affairs support functions
- Vendor Approval
- GMP internal audit and training
Requirements
Requirements
- University Qualifications: Doctorate of Pharmacy (Pharm.D).
- Nature and length of previous experience: 2 years experience in registration of Biopharma and Pharma products in Ir-FDO.
- Soft Skills and Personality traits: familiar with Chargoon and TTAC application .