Job Description
1. Performs scheduling and scheduling and compiling executive programs for document creation, internal inspections and monitoring of device quality, process validation, revalidation and calibration . 2. Makes documentation of development. 3. Performs internal inspection at specified intervals and report. 4. Carries out statistical quality control and analysis of production and laboratory data and assess the manner in which standards are implemented in the production and laboratory and to explain the appropriate methods for implementation of standards. 5. Provides suggestions and planning to improve production conditions and product quality. 6. Reviews batch records of each product record. 7. Updates job knowledge through participation in educational opportunities. 8. Provides a periodic / case performance report, along with an analysis of the required seniority. 9. Carries out other assignments in the field of organizational duties by superiors.
Requirements
- Mastering the GMP PIC / S and EU GMP requirements and the FDA, ICH and WHO Guides - Ability to evaluate and monitor production processes - Ability to design a report and provide appropriate corrective and preventive action - Familiarity with the rules of the Food and Drug Organization and international organizations - Understanding the different methods of production, especially the production processes in aseptic conditions - Familiarity the requirements of ISO 10015 and 9001 standards and document design and control - Familiarity the requirements of ISO 17025 - Relative proficiency in English
