Job Description
Job Description
• Direct and continuous supervision of all technical processes related to the production, import, or distribution of pharmaceutical products in accordance with the regulations of the Food and Drug Administration.
• Full proficiency in the importation of urgently required medicines requested by the Food and Drug Administration.
• Ensuring the proper implementation of GDP/GMP requirements and applicable guidelines.
• Reviewing, approving, and controlling technical documentation, including SOPs, Batch Records, COAs, and quality reports.
• Monitoring the storage, warehousing, and distribution conditions of medicines and ensuring compliance with applicable legal requirements.
• Handling quality deviations, complaints, recalls, and the implementation of corrective and preventive actions (CAPA).
• Excellent communication with the experts of the Food and Drug Administration.
• Providing specialized responses to inspections, correspondence, and requirements of the Food and Drug Administration.
• Providing technical and managerial reports to the company management and relevant legal authorities.
Qualifications
• Doctor of Pharmacy (Pharm.D.) degree.
• Relevant work experience: At least 5 years of experience in the importation of urgently required medicines.
• Fulfillment of the legal requirements for appointment as the Technical Responsible Person in accordance with the regulations of the Food and Drug Administration.
• Full familiarity with TTAC.
• Proficiency in documentation and report writing.
• Full knowledge of GMP, GDP, GSP principles and Quality Management Systems.
• Full familiarity with the laws, regulations, and guidelines of the Food and Drug Administration.
• Proficiency in the regulations governing the registration of the wholesaler, importation, and distribution of urgently required medicines.
• Skills in preparing and reviewing technical documentation and specialized reports.
• Ability to make decisions, manage and resolve problems, and work effectively as part of a team.
• Adequate proficiency in Microsoft Office software and relevant systems.
Personal Attributes
• High level of responsibility and accuracy.
• Ability to plan and manage time effectively.
• Strong communication and interaction skills with organizations.
• Commitment to professional ethics and confidentiality of information.
