Senior Documentation Specialist

Job Description

•      Responsible for compiling, updating, maintaining and distributing documents related to the Quality Management System (QMS) at Group HQ.
•     Design, document and maintain internal processes and procedures to ensure compliance with quality management standards and GMP based on internal requirements and international regulations.
•       Coordinate with various teams in the group (at Division and Company levels) to collect and compile quality-related documents.
•      Support internal and external audit processes.
•       Manage quality-related documentation in electronic documentation systems (eDMS).
•     Create and modify documentation for new processes and update existing processes, and be able to contribute to the creation of digital systems.
•      Analyze and report on documentation performance in relation to compliance with legal and organizational requirements.

Requirements:

•       Mastery of documentation processes and use of relevant software, as well as complete mastery of the principles and requirements of documentation in the pharmaceutical field.
•     Familiarity with quality management and GMP references and standards, including PICs, ISO, FDA, ICH and other international regulations.
•      Ability to write technical and scientific documentation in Persian and English.
•     Ability to analyze documentation and report to management.
•      Skill in collaborating and coordinating with different teams at HQ level as well as with all divisions and companies of the Cobel Group. 
•       Ability to manage documentation projects in high-pressure environments.