Mohamed Ramzy

final release managerFull Time

• Job Details:Responsibilities As a Quality Assurance Manager • Responsible for Documentations Review and Final Release team for daily Control inspection and follow up manufacturing areas. • Training of the Documentations Review and Final Release team and Provide them with the documented quality standards as guidelines for their day-to-day work. • Responsible of QMS documentation : - - Review BPR and COA during the production process stages and issue a permit for the next stage - Make sure that the production process had completed without any defects before final release - NCR/CAPA System and follow up. Job description • Assist Quality Assurance Director for documents review and final release in all aspects of Supervision employees. • Supervise Documentation team who review BPR of products at different stages of production. • Review all SOP(s) before approval from QA director to assure the compliance of all activities with GMP regulations. • Handling of deviations and share investigation with relevant directorate. • Evaluate CAPA responses to assess findings for adequacy, including root cause and timelines. • Handling Change Control Procedure & Evaluate the impact of change & follow up change implementation and Post change evaluation. • Creates Certificates of Analysis for All dosage forms • Received and recorded Samples of Analysis • Follow up to the filling, Coating, Packaging Notification Issues • Preparation in-process Validation reports • Reviewing of Batch Production Records (Preparation – Packaging ) • Preparation of MOH requirements • Follow up Operations that MOH inspector will draw samples for MOH Labs and review papers reconciliations of the products • Final release for each dosage forms • Creates and reviews SOP • Performs archive of Paper (Filing system) • Follow up of Retained samples store to ensure that there is a retained samples for each production batch • As a member in supply Chain committee. • As a member in New Products committee. • Study the reasons and respond to the general administration of the drug shortage in the MOH Retained Sample System: • Ensure that there is a retained sample for each Batch Production. • Responsible for keeping and follow up retained samples. Ministry of Health system: • Follow-up operations that the Ministry of Health inspector will draw samples for the Ministry of Health laboratories. • Review the operating files and registration papers before visiting the Inspector of the Ministry of Health • Follow up the arrival of the Ministry of Health reconciliations of the products that were withdrawn by the Inspector of the Ministry of Health • Coordination with the Inspector of the Ministry of Health visits to production areas and warehouses • Study the reasons and respond to the general administration of the Drug shortage in the Ministry of Health. Training System: • Determine the training needs in the first of year for all employee(s). • Evaluation of all employee(s) before and after conducting the training programs to determine the effectiveness of training on their performance. • Evaluation of the new employees and monitoring of their training plan and evaluation of their performance.