Mamoud Moussa

 Manage the pharmaceutical regulatory GxP regulations throughout the manufacturing site, including handling internal and external auditing activities.
 Maintain and responsible KPI’s for managing, measuring and improving QMSs performance.
 Lead the quality operation team to maintain the manufacturing processes to standard KPIs.
 Handle of CAPA, investigating non-conformances and deviations to change control procedures based on a well-developed Quality Risk Management (QRM) system.
 Manage the products manufacturing process development to meet the optimized quality standards.
 Task owner of the QMSs (ISO standards) implementation, auditing and certifications.
 Create quality risk management system adhering international pharmaceutical regulations.
 Responsible the implementation of the site Validation Master Plan (VMP) for machine, equipment utilities qualification, process and method validation.

 Prepared and updated the required validation master plans (VMP) and schedules.
 Responsible for developmental stages of process validation and risk assessment for hazardous products.
 Managed manufacturing machine performance qualification plans and reported on over all equipment efficiency (OEE).
 Reported on outcome of regulatory inspections and ensure responses are complete and managed.
 Lead manufacturing process improvement projects engaging Six Sigma roadmaps for a wide range of drug dosage forms
 Ensure that procedures and specifications are appropriate and followed.
 Performed deviation investigations for non-conformances to process, methods validation and performance qualification protocols acceptance criteria.
 Responsible for periodic GxP internal and external audit compliance, and quality management reviews.

 Produced Reports on the GMP compliance in the manufacturing site.
 Created qualification and validation master plans, protocols and reports
 Responsible for integrating the GMP requirement within the ERP (ORACLE) system.
 Created, conducted and following GMP, GSP, GLP and safety training programs.
 Led quality risk assessment and control plans throughout the manufacturing site.
 Evaluated and ratified technical deviation, CAPA and change control procedures.
 Handled continuous improvement projects focusing on product quality and process efficiency.

 Responsible for the in-process quality control activities including sampling, testing and reporting.
 Created deviations, root cause analysis reports and CAPA plans based on QMS requirements.
 Evaluated the product quality during manufacturing process validation stages.
 Handled product customer complaints according GMP standards.
 Executed training program according to quality management system.
 Responsible for microbiological environmental monitoring and aseptic process validation plans.
 Created quality operations SOP’s, Annual Product Review (APR).
 Carried out the release of product batch on SAP system.

 Responsible for clean rooms microbiological control for sterile and non-sterile area.
 Responsible for microbiological water analysis, raw material, bulk and finished products.
 Handled clean room qualification and aseptic process validation.
 Produced validation and routine test method for sterile and non-sterile products.
 Performed validation and routine sterility testing and Endo-toxin limit test.
 Handled cleaning validation projects in sterile and non-sterile manufacturing sites.
 Lead dry and steam sterilization equipment and process validation.
 Carry out of specification (OOS) result investigation reports.

 Implementation for quality systems ISO 9001/2000 and HACCP standards.
 Coordinating internal auditing.
 Maintenance of quality records.
 Change control.
 Establishing training programs.