● Conduct, review, and implementation of internal audits. Suggest the CAPA and close the non-compliance report observed during internal audits and review the compliance of both internal and external audits.
● Review, approve, and implementation of risk assessment programs.
● Implementation of training programs and current Good Manufacturing Practices and approve layouts.
● Review quality management systems and approve the documents.
● Review and update of Site Master File, Validation Master Plan, Quality Manual, Calibration Master Plan, and batch record and analysis data and batch release.
Requirements
● Skilled in: GMP; Cleaning and Process Validation; Utilities and Equipment Qualification; Instruments Calibration; Corrective and Preventive Action (CAPA). Change control, Risk Management, Quality Management systems, Quality audit.
● Master's degree or Professional Doctorate in Pharmacy or Chemistry.
● At least 5 years of managerial experience in pharmaceutical companies.
● Fluent in English.
● Leadership skills and background.
● Good knowledge of GMP, ISO, and SOPs.
● Good command of computer skills (Microsoft Office and Windows).
● Ability to work under pressure and handle multiple tasks and deadlines.
● A resident of Tehran province or Saveh and its suburbs.