● Development of DMF and SMF and submission to the drug supervision administration of Iran FDA.
● Liaising with customers and the regulatory authorities regarding quality matters, including hosting inspections and responding to observations as needed.
● Supervising the implementation of documentation through the organization based on DMF and SOPs.
● Supervising the proper implementation of GMP through the organization.
● Investigating and resolving problems in the field of production and noting any deviation from the standards and taking required actions.
● Establishing contacts and communication with research and development Dept., production, quality control and laboratories, warehouses and etc.
● Establishing contacts and communication with related organizations such as Food and drug Administration, Ministry of Health, Treatment and Medical Education, Standard Office, etc.
● Carrying out internal inspections and taking the required actions as needed.
Requirements
● Having an approved Pharm D. university certificate.
● Full mastery of PIC/S standard and related principles and rules of GMP, GLP, GSP and GDP.
● 5+ years of related experiences in pharmaceutical industry including all quality departments of QC, QA and regulatory Affairs.
● Fluency in English language, especially in writing, emailing and speaking.
● Soft skills: Management, teamwork, good communication and negotiation skills, positivity, problem Solving.
● Hard skills: Good knowledge of ICDL especially in Office software of Excel and Outlook.