- Supervision of all activities related to the quality of products according to the national and international standards including GMP, GLP, GSP, GDP and etc.
- Managing for preparation of all required documents such as guidelines, SOPs, specifications, certificates and reports for different departments.
- Managing the process of registration of products and preparing CTDs and other requirements.
- Batch Control and release, to check and monitor all aspects of GMP and related issues, to communicate with IRFDA and other foreign authorities as required, to accompany the auditors during GMP inspections
- supervise production and studying related documents
- Gathering and preparing the documents for Iran Drug List, Brand Registration, Renewal and Variation
- Submitting the required documents for registration to Iran MOH
- Monitoring and following the registration process both with Iran MOH and related Foreign Companies
- Maintaining familiarity with imported and to be imported foreign company products
- Keeping up-to-date with changes in regulatory legislation and guidelines
- Obtaining marketing permission from Iran MOH according to the regulation
- Acting as a link between companies and Iran MOH, ensuring that products are manufactured and distributed in compliance with appropriate legislation
- Writing comprehensible, user-friendly, clear Persian product information leaflets and labels
- Ensuring that quality standards are met and submissions meet strict deadlines
University degree in Pharmacy
At least 2 years of experience in pharmaceutical and preferably biopharmaceutical industry.
- Capable to work in a team;
- Independent, motivated and initiative;
- Strong communication and negotiation skills;
- Hard working and Integrated;
- Task oriented;
- Result oriented
Language Skills: Fluent in English
Computer Skills: MS Office programs
Current Residence: Tehran
Travel Requirements: Within the Country & other Countries
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Biosun Pharmed Co. is a subsidiary of Barakat Pharmaceutical Holding Co. registered on October 20, 2012. The company's fields of activity include research, development and production of biosimilar products, vaccines, monoclonal antibodies and peptide medications. This company operates in three centers: the main factory is located in the Barakat pharmaceutical science and technology town, located in the Alborz province, the biotechnology and peptide site called “Biosun Darou” in Yaftabad, as well as the headquarters of the company in Tehran.
Our mission is to produce vaccines and healing drugs for domestic and foreign markets in accordance with state-of-the-art international quality standards. The motivation behind this production is to alleviate pain in patients who deserve to live a fulfilling life. Knowledge-based technology is a timeless companion to our products. This approach guarantees the stability of domestic production and brings independence to the country. Our prominent attribute is the commitment and responsibility to improve the country's pharmaceutical status.
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