Walid Nafea Email and Phone Number

Supervising of all GSP/GDP requirements and quality activities.

- Preparation and reviewing of Standard Operating Procedures (SOPs) to ensure their compliance with their regulatory and group requirements.- Update, technical reviewing, and maintenance of documentation system.- Handling of internal audits & external audits issuing of the action plan and following up the implementation of action plan.- Handling of non-conformances cases, investigation process, identification of root cause and determination of required CAPA and its follow-up.- Handling of quality complaints, investigation process and issuing of CAPA.- Check received shipments including truck cleaning, physical appearance, quantities, and identifications.- Monitoring of storage conditions of received products according to manufacturer recommendations.- “Shipments release”, ensuring that finished products are suitable for its intended use before releasing to the market.- Assessment of transportation conditions for received shipments to take the release decision.- Products quality monitoring through delivery to ensure its integrity.- Download and setup for data loggers’ data during transportation.- Check the dispatching process and products quality.- IPQA for warehousing activities.- Following up on all SFDA requirements and undertaken cases.- Monitoring of return processes.- Handling and follow-up of the recall process.- Handling of destruction activities.- Following of temperature mapping. - Handling of ‘on-job Training’ for warehouse employees.

A. Documentation:-Establishment of documentation system, complete responsibility of documents control system and documents maintenance.-Preparation and review of Standard Operating Procedures (SOPs) to ensure their compliance with regulatory and corporate requirements.-Technical reviewing all department's procedures & SOPs (validation protocols, validation reports, production, QC, warehouse, engineering, purchasing, human resource and non-technical departments) and controlling the required changes for master documents.-Reviewing of batch records, ensuring that the relevant tests are carried out and ensuring that finished products are suitable for its intended use before releasing to the market.-Manage the process of change control and asses in combined risk assessment, define required task for effective implementation and follow up its progress and evaluation of change. -Regular periodic products quality review (APR/PQR), evaluation for the results of the review and issuing an assessment report contain the required or recommended action to be taken for improvement.-Responsible for tracking and trending of out-of-specification results, failure investigation and non-conformance.-Responsible for management review arrangement & follow up of its recommendations.-Following of ISO 9001, 14001, 18001 requirements. -Water system trend analysis.-Rejection & Destruction activities.B. Validation and qualifications:-Implementation and follow up on the validation & qualification projects:*Solid Area equipment qualification.*Building qualification*Supplier qualification*Re-qualification of HVAC system.-Following of calibration activities and thermal validation activities.C. Investigation of Deviations:-Participate in investigations of deviations, identification of root cause and determination of remedial corrective and preventive actions.D.Internal Auditing:-Performs audits, Prepares audit and action plans.E. Initiate Quality Risk Management and follows up.

* Responsible for the documents controlling of onshore and offshore Oil/Gas projects of Tecnomare Egypt Ltd. inside and outside Egypt. * Documents distribution and coordination the official transmittals with clients and Tecnomare Italy. * Establishment of documentation system for each Oil/Gas project.

* Establishment of Documentation system, complete responsibility of documents control system. * Participate in establishment of QA procedures (e.g. self-inspection, change control, supplier qualification, deviation handling, release, return, recall, complaint, batch record revision, re-packaging, dispensing, rejection / destruction and IPQA activities). * Technical review all department's procedures & SOPs (production, QC, warehouse, engineering and purchasing).* Product quality review.* Issuance of batch records (copying & stamping from the masters).* Qualification and re-qualification projects, e.g. qualification and Monitors water system, HVAC system, machines/equipments and building qualification. * Responsible for management review arrangement & follow up of its recommendations.* On-Job Trainer and internal Trainer. * Responsible for tracking and trending of out-of-specification results, failure investigation, nonconformance, deviations, change controls and complaints.* Issuing audit plan, execution of audit, issuing NCRs and follow up CAPA. * Participation in establishment of non aseptic process and cleaning validation system.* Q.A. Inspector in Solid section (tablets, capsules, human powder and vet. Powder)* Implementation and follow up on management review and QRM activities.