Faed Asfour Email & Phone Number

Riyadh, Saudi Arabia

Introduction of a new system to manage the Calibration activities starting from the Calibration Master Plan, annual schedule, reports, formats design, measuring devices specs, grouping of the measuring devices under the same machine, reports issuance, end to end calibration activities, and control of issued reports and certificates.Review the Process Validation System and Cleaning Validation System against the latest legislatives and guidelines, upgrade the method of implanting the daily tasks and managing the personnel KPIs.Issuance of a new system to in-house validate AHUs and HVAC frequent performance; using newly issuance of the legislative standard procedures with the related records and formats, review the latest guidelines and reflect into the newly issued system, introducing new tests and verifications starting from Risk Assessment of the current as built status of the HVAC System until reports issuance and documents control.Review of the Process Validation System and Cleaning Validation System against the legislative guidelines, improve the dealing with daily updates and personnel KPIs.Newly issuance of Equipment Validation Master Plant as per the last issued guidelines, as well as issuance of the related procedures and execution strategies.

Amman-Jordan

Managing of validation and calibration functions for the non-sterile GMP manufacturing facility. This include managing of department personnel as well as hands-on execution of validation protocols and equipment calibrations.Major Responsibilities:- Develop protocols for executing equipment and facility qualifications for the pharmaceutical functions.- Execute protocols, including coordination of activities with other departments, hands-on performance of protocol requirements, data analysis and final report writing.- Provide the validation component in assessment of manufacturing deviations and investigations.- Perform the validation assessment for change control submissions.- Provide detailed review of calibration and validation failures, using good investigative technique and risk-based evaluations.- Maintain accurate tracking of validation studies, equipment and facility status.- Determine calibration needs of equipment and establish calibration procedures, tolerances, and schedules based on criticality of application and following good calibration/metrology-based evaluations.- Develop, write and update departmental SOPs.- Manage departmental personnel and train staff as needed.- Review all new equipment within the facility to determine validation and calibration requirements.- Provide validation/calibration subject matter expertise during regulatory and customer inspections and for new manufacturing projects.

Amman Governorate, Jordan

Managing the validation activities for the non-sterile GMP manufacturing facility. This includes of department personnel as well as hands-on execution of validation protocols and reports, as well as implementing the related studies.Major Responsibilities:- Develop protocols for executing equipment and facility qualifications for the pharmaceutical functions.- Execute protocols, including coordination of activities with other departments, hands-on performance of protocol requirements, data analysis and final report writing.- Provide the validation component in assessment of manufacturing deviations and investigations.- Perform the validation assessment for change control submissions.- Provide detailed review of validation failures, using good investigative technique and risk-based evaluations.- Maintain accurate tracking of validation studies, equipment and facility status.- Develop, write and update departmental SOPs.- Manage departmental personnel and train staff as needed.- Review all new equipment within the facility to determine validation and calibration requirements.- Provide validation subject matter expertise during regulatory and customer inspections and for new manufacturing projects.

Rahma Pharmaceuticals Co.

Managing a group of engineers responsible for executing equipment, facility and utility validation at a commercial/clinical pharmaceuticals-manufacturing site. Set group goals, drive for progress, create execution strategies, train and develop internal talent and assess performance against goals. Write validation plans, protocols and summary reports using provided templates. Collect and review validation data and dispositions tests. Review and approve protocols executed by others for compliance with validation policies and procedures. Provide input towards the development of validation SOP’s and templates. Support regulatory submissions and internal or external audits. Integrate corporate policies, business needs and regulatory requirements into project execution. Implement lean engineering concepts. Provide technical and troubleshooting support to project teams. Interact with leaders from other sites, disciplines and senior management.

Dammam, Saudi Arabia

Establishment of the Microbiology lab. based on GAP Analysis as per #SFDA and current guidelines.

Amman-Jordan

Establishing and Managing the Microbiology lab activities, issuing the lab systems and documentation pricedures.

Jovac

production of Bacterial Vaccines as follow :Brucella melitensis strain Rev-1, Brucella abortus strain S19, Salmonella enteritidis PT4, Salmonella gallinarium 9R, Anthrax live vaccines, Pasteurella multocida and Mannhiemia haemolytica according to OIE, CFR, and European Pharmacopeias references. During that time, a lot of techniques such as sterilization, fermentation and titration of bacterial cultures and toxins as well as calculations, composition and preparation of inactivated vaccines had been conducted.

Master'S Degree, Biotechnology, 3.64/4.00

Bachelor'S Degree, Applied Biology, 74/100

Lead Auditor, Quality System