Job Description
-Development, periodic review, revision and implementation of SOPs and quality control unit instructions -Identify critical points in the manufacturing process and specify sampling procedures to be used at these points -Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested. -Review documents as CTD, PMFs, to fulfill MOH requirement for registration. -Complaint handling -Pharmacovigilance system installation -Contracted Product Management -GMP Inspection of suppliers -Management of new drugs for inclusion on the Drug List -Manage and monitor licensing and troubleshooting issues(API,FP) -Participate in equipment reviews(FAT)
Requirements
-Education: PharmD. Pharmacists -Over 5 years’ relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Regulatory affairs -Good history and knowledge on working with MOH and IFDA -Fluency in writing, reading and speaking of English language -Regulatory requirements of organizations (ISO) -Experienced in Regulatory affairs -Ability for working travel (national/international)
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Seniority
