AHMED SELIM

Documentation Section HeadFull Time

• Job Details:- Manages the central repository of GMP documentation and acts as a focal point for all Documentation matters. - Tracking the pending documents, notifying the involved party for tacking appropriate action on the pending documents. - Filling and archiving company documents in both electronic and physical forms. - Check completeness, accuracy, and authenticity of SOPs and other documents. - Maintaining a solid documentation system and verifying that the documentation system is in place and well maintained. - Control, issuance, distribution, and withdrawal all the required documents. - Responsible for security accessibility of all the documents available in QA [hard and soft copies] through keys and protective passwords and specify the necessary permissions to access documents in the electronic management system. - Archive, control, and retrieve records as and when needed. - Preparing the approved document list and preparing the document status on regular basis. - Completing various administration duties of the QA department. - Preparing documents for ISO certificates (SOPs, SMF, QM, QP). - Monitoring documents compliance with GDP and company QEHS. - Make all arrangements for hosting the internal & external audits and provide the required documentation on request. - Control, Maintain and withdraw Specifications, Methods of Analysis, MFRs and MPRs. - Check, Scan & Maintain the master Batch Record. - Responsible for daily issuance, stamping and revision of the required BMRs and BPRs for production after checking dispensing orders and to assure compliance with BOMs before delivery to Production Department. - Trained the documentation team to control documents and to assure compliance with the quality system.